Trial Outcomes & Findings for Open-Label, Safety Study of Lofexidine (NCT NCT02363998)
NCT ID: NCT02363998
Last Updated: 2022-03-22
Results Overview
Subjects with at least 1 TEAE occurring on days 1-14.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
286 participants
Primary outcome timeframe
Days 1-14
Results posted on
2022-03-22
Participant Flow
Participant milestones
| Measure |
OL: Lofexidine HCl
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested.
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|---|---|
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Overall Study
STARTED
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286
|
|
Overall Study
COMPLETED
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168
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|
Overall Study
NOT COMPLETED
|
118
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label, Safety Study of Lofexidine
Baseline characteristics by cohort
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested.
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|---|---|
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Age, Continuous
|
37.5 years
STANDARD_DEVIATION 10.32 • n=5 Participants
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Sex: Female, Male
Female
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98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
242 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
218 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Height (cm)
|
173.2 cm
STANDARD_DEVIATION 9.99 • n=5 Participants
|
|
Weight (kg)
|
78.4 kg
STANDARD_DEVIATION 17.96 • n=5 Participants
|
|
BMI (kg/m^2)
|
26.1 kg/m^2
STANDARD_DEVIATION 5.43 • n=5 Participants
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PRIMARY outcome
Timeframe: Days 1-14Subjects with at least 1 TEAE occurring on days 1-14.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
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|---|---|---|---|---|---|---|---|---|---|
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Overall Occurrence of Treatment Emergent Adverse Events (TEAEs)
|
270 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Days 1-14Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
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|---|---|---|---|---|---|---|---|---|---|
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Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs)
|
2 Participants
|
—
|
—
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—
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—
|
—
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—
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—
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—
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PRIMARY outcome
Timeframe: Days 1-14Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
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|---|---|---|---|---|---|---|---|---|---|
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Overall Treatment Emergent Adverse Events (TEAEs) by Severity
Mild
|
104 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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Overall Treatment Emergent Adverse Events (TEAEs) by Severity
Moderate
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158 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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Overall Treatment Emergent Adverse Events (TEAEs) by Severity
Severe
|
8 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Day 1 to Day 14Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
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Occurrence of Per Protocol Adverse Events of Special Interest (AESI)
Orthostatic hypotension
|
96 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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Occurrence of Per Protocol Adverse Events of Special Interest (AESI)
Orthostatic bradycardia
|
0 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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Occurrence of Per Protocol Adverse Events of Special Interest (AESI)
Syncope
|
1 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Day 1 to Day 14Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
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|---|---|---|---|---|---|---|---|---|---|
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Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal
Opioid Withdrawal Related Adverse Events
|
233 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal
Non-Opioid Withdrawal Related Adverse Events
|
208 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Participants Analyzed does not match the Participant Flow because some patient data was missing for the visit.
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
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|---|---|---|---|---|---|---|---|---|---|
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Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Screening
|
121.9 mmHg
Standard Deviation 11.85
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 1 Observed
|
122.2 mmHg
Standard Deviation 13.89
|
109.7 mmHg
Standard Deviation 15.47
|
111.1 mmHg
Standard Deviation 16.07
|
112.6 mmHg
Standard Deviation 15.91
|
114.1 mmHg
Standard Deviation 15.38
|
116.9 mmHg
Standard Deviation 17.94
|
116.7 mmHg
Standard Deviation 16.82
|
—
|
—
|
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Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 1 Change
|
—
|
-12.2 mmHg
Standard Deviation 15.25
|
-10.8 mmHg
Standard Deviation 15.21
|
-9.4 mmHg
Standard Deviation 16.05
|
-8.0 mmHg
Standard Deviation 15.12
|
-5.2 mmHg
Standard Deviation 19.16
|
-5.3 mmHg
Standard Deviation 17.69
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 2 Observed
|
116.8 mmHg
Standard Deviation 15.77
|
114.8 mmHg
Standard Deviation 15.82
|
114.5 mmHg
Standard Deviation 14.30
|
115.7 mmHg
Standard Deviation 16.20
|
117.4 mmHg
Standard Deviation 16.55
|
119.7 mmHg
Standard Deviation 18.01
|
117.9 mmHg
Standard Deviation 16.04
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 2 Change
|
-5.0 mmHg
Standard Deviation 16.21
|
-7.0 mmHg
Standard Deviation 15.65
|
-7.3 mmHg
Standard Deviation 15.53
|
-6.2 mmHg
Standard Deviation 16.43
|
-4.5 mmHg
Standard Deviation 17.10
|
-2.1 mmHg
Standard Deviation 18.03
|
-3.9 mmHg
Standard Deviation 17.24
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 3 Observed
|
116.0 mmHg
Standard Deviation 15.66
|
116.1 mmHg
Standard Deviation 15.75
|
114.3 mmHg
Standard Deviation 14.71
|
116.9 mmHg
Standard Deviation 16.21
|
116.9 mmHg
Standard Deviation 15.90
|
118.2 mmHg
Standard Deviation 16.64
|
117.1 mmHg
Standard Deviation 15.70
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 3 Change
|
-5.9 mmHg
Standard Deviation 16.38
|
-5.8 mmHg
Standard Deviation 16.22
|
-7.5 mmHg
Standard Deviation 16.40
|
-5.0 mmHg
Standard Deviation 17.30
|
-5.0 mmHg
Standard Deviation 16.88
|
-3.8 mmHg
Standard Deviation 17.08
|
-4.9 mmHg
Standard Deviation 16.17
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 4 Observed
|
116.2 mmHg
Standard Deviation 15.32
|
113.7 mmHg
Standard Deviation 14.26
|
114.4 mmHg
Standard Deviation 14.85
|
118.6 mmHg
Standard Deviation 14.77
|
118.7 mmHg
Standard Deviation 14.68
|
120.0 mmHg
Standard Deviation 15.24
|
117.7 mmHg
Standard Deviation 13.90
|
117.0 mmHg
Standard Deviation 12.44
|
115.7 mmHg
Standard Deviation 8.60
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 4 Change
|
-6.0 mmHg
Standard Deviation 15.47
|
-8.1 mmHg
Standard Deviation 14.65
|
-7.7 mmHg
Standard Deviation 14.77
|
-3.7 mmHg
Standard Deviation 15.31
|
-3.0 mmHg
Standard Deviation 15.24
|
-1.8 mmHg
Standard Deviation 16.36
|
-4.0 mmHg
Standard Deviation 16.10
|
-4.7 mmHg
Standard Deviation 14.54
|
-5.5 mmHg
Standard Deviation 11.15
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 5 Observed
|
115.4 mmHg
Standard Deviation 14.76
|
114.8 mmHg
Standard Deviation 15.06
|
115.2 mmHg
Standard Deviation 13.69
|
116.3 mmHg
Standard Deviation 15.72
|
117.1 mmHg
Standard Deviation 14.78
|
117.2 mmHg
Standard Deviation 14.62
|
117.0 mmHg
Standard Deviation 13.48
|
116.7 mmHg
Standard Deviation 12.12
|
118.3 mmHg
Standard Deviation 11.06
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 5 Change
|
-6.3 mmHg
Standard Deviation 15.86
|
-7.1 mmHg
Standard Deviation 16.87
|
-6.6 mmHg
Standard Deviation 15.46
|
-5.6 mmHg
Standard Deviation 16.76
|
-4.8 mmHg
Standard Deviation 16.64
|
-4.8 mmHg
Standard Deviation 15.46
|
-4.9 mmHg
Standard Deviation 14.93
|
-6.3 mmHg
Standard Deviation 16.02
|
-4.7 mmHg
Standard Deviation 14.97
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 6 Observed
|
115.2 mmHg
Standard Deviation 16.13
|
113.4 mmHg
Standard Deviation 14.81
|
114.0 mmHg
Standard Deviation 14.52
|
116.8 mmHg
Standard Deviation 16.74
|
116.6 mmHg
Standard Deviation 15.03
|
117.5 mmHg
Standard Deviation 16.57
|
118.4 mmHg
Standard Deviation 16.46
|
118.7 mmHg
Standard Deviation 15.19
|
122.0 mmHg
Standard Deviation 15.14
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 6 Change
|
-6.5 mmHg
Standard Deviation 15.89
|
-8.7 mmHg
Standard Deviation 14.74
|
-8.0 mmHg
Standard Deviation 14.88
|
-5.1 mmHg
Standard Deviation 16.57
|
-5.5 mmHg
Standard Deviation 15.10
|
-4.5 mmHg
Standard Deviation 17.13
|
-3.5 mmHg
Standard Deviation 15.41
|
-3.6 mmHg
Standard Deviation 18.44
|
0.4 mmHg
Standard Deviation 19.39
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 7 Observed
|
118.0 mmHg
Standard Deviation 16.44
|
116.4 mmHg
Standard Deviation 14.82
|
114.9 mmHg
Standard Deviation 15.45
|
117.9 mmHg
Standard Deviation 11.32
|
117.9 mmHg
Standard Deviation 12.20
|
121.1 mmHg
Standard Deviation 14.84
|
118.5 mmHg
Standard Deviation 12.08
|
120.8 mmHg
Standard Deviation 12.99
|
116.3 mmHg
Standard Deviation 9.96
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 7 Change
|
-4.4 mmHg
Standard Deviation 16.50
|
-5.4 mmHg
Standard Deviation 14.82
|
-5.1 mmHg
Standard Deviation 12.87
|
-3.0 mmHg
Standard Deviation 13.44
|
-3.0 mmHg
Standard Deviation 11.43
|
0.2 mmHg
Standard Deviation 15.23
|
-1.7 mmHg
Standard Deviation 16.30
|
2.6 mmHg
Standard Deviation 16.29
|
-5.1 mmHg
Standard Deviation 12.91
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 8 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
118.4 mmHg
Standard Deviation 11.69
|
122.8 mmHg
Standard Deviation 13.15
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 8 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.8 mmHg
Standard Deviation 14.03
|
2.1 mmHg
Standard Deviation 13.41
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 9 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
124.3 mmHg
Standard Deviation 13.14
|
122.3 mmHg
Standard Deviation 16.51
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 9 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.6 mmHg
Standard Deviation 14.43
|
1.4 mmHg
Standard Deviation 14.75
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 10 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
122.2 mmHg
Standard Deviation 14.41
|
124.3 mmHg
Standard Deviation 17.24
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 10 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.2 mmHg
Standard Deviation 14.12
|
3.6 mmHg
Standard Deviation 17.67
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 11 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
121.2 mmHg
Standard Deviation 12.54
|
125.1 mmHg
Standard Deviation 14.16
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 11 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.7 mmHg
Standard Deviation 13.52
|
4.6 mmHg
Standard Deviation 15.39
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 12 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
126.3 mmHg
Standard Deviation 9.75
|
120.4 mmHg
Standard Deviation 12.22
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 12 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.3 mmHg
Standard Deviation 9.20
|
-1.4 mmHg
Standard Deviation 12.10
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 13 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
124.8 mmHg
Standard Deviation 12.48
|
123.5 mmHg
Standard Deviation 10.61
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 13 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 mmHg
Standard Deviation 13.62
|
3.0 mmHg
Standard Deviation 14.38
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 14 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
128.0 mmHg
Standard Deviation 12.62
|
—
|
|
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Day 14 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.6 mmHg
Standard Deviation 10.80
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 3 Observed
|
111.2 mmHg
Standard Deviation 16.61
|
108.1 mmHg
Standard Deviation 17.15
|
109.1 mmHg
Standard Deviation 15.40
|
107.8 mmHg
Standard Deviation 15.97
|
110.0 mmHg
Standard Deviation 15.99
|
110.8 mmHg
Standard Deviation 15.77
|
110.5 mmHg
Standard Deviation 16.19
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 3 Change
|
-11.4 mmHg
Standard Deviation 16.25
|
-14.4 mmHg
Standard Deviation 17.22
|
-13.5 mmHg
Standard Deviation 15.73
|
-14.8 mmHg
Standard Deviation 17.63
|
-12.6 mmHg
Standard Deviation 17.16
|
-11.9 mmHg
Standard Deviation 16.61
|
-12.2 mmHg
Standard Deviation 16.09
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 4 Observed
|
112.4 mmHg
Standard Deviation 15.93
|
107.9 mmHg
Standard Deviation 16.18
|
110.9 mmHg
Standard Deviation 17.93
|
109.7 mmHg
Standard Deviation 14.74
|
112.4 mmHg
Standard Deviation 15.12
|
111.7 mmHg
Standard Deviation 15.81
|
111.1 mmHg
Standard Deviation 14.79
|
116.6 mmHg
Standard Deviation 15.11
|
113.4 mmHg
Standard Deviation 11.60
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 4 Change
|
-10.3 mmHg
Standard Deviation 15.29
|
-14.4 mmHg
Standard Deviation 15.07
|
-11.9 mmHg
Standard Deviation 16.69
|
-13.2 mmHg
Standard Deviation 15.66
|
-9.9 mmHg
Standard Deviation 15.25
|
-10.8 mmHg
Standard Deviation 16.21
|
-11.3 mmHg
Standard Deviation 15.89
|
-6.1 mmHg
Standard Deviation 17.61
|
-8.8 mmHg
Standard Deviation 13.77
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 5 Observed
|
111.3 mmHg
Standard Deviation 15.97
|
108.9 mmHg
Standard Deviation 15.41
|
109.2 mmHg
Standard Deviation 14.75
|
109.5 mmHg
Standard Deviation 15.75
|
110.8 mmHg
Standard Deviation 14.72
|
110.2 mmHg
Standard Deviation 16.55
|
111.4 mmHg
Standard Deviation 15.49
|
114.6 mmHg
Standard Deviation 12.29
|
116.1 mmHg
Standard Deviation 10.69
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 5 Change
|
-11.1 mmHg
Standard Deviation 15.19
|
-13.6 mmHg
Standard Deviation 15.83
|
-13.2 mmHg
Standard Deviation 16.10
|
-13.0 mmHg
Standard Deviation 17.91
|
-11.7 mmHg
Standard Deviation 16.44
|
-12.3 mmHg
Standard Deviation 17.23
|
-11.0 mmHg
Standard Deviation 16.42
|
-8.4 mmHg
Standard Deviation 14.43
|
-7.5 mmHg
Standard Deviation 15.02
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 6 Observed
|
112.2 mmHg
Standard Deviation 16.44
|
108.8 mmHg
Standard Deviation 15.61
|
110.2 mmHg
Standard Deviation 15.25
|
109.1 mmHg
Standard Deviation 16.83
|
110.7 mmHg
Standard Deviation 16.44
|
110.9 mmHg
Standard Deviation 16.91
|
112.7 mmHg
Standard Deviation 16.24
|
116.6 mmHg
Standard Deviation 15.47
|
116.4 mmHg
Standard Deviation 16.05
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 6 Change
|
-10.4 mmHg
Standard Deviation 16.12
|
-14.0 mmHg
Standard Deviation 17.01
|
-12.6 mmHg
Standard Deviation 15.30
|
-13.8 mmHg
Standard Deviation 17.45
|
-12.3 mmHg
Standard Deviation 16.78
|
-12.0 mmHg
Standard Deviation 17.84
|
-10.0 mmHg
Standard Deviation 16.10
|
-5.8 mmHg
Standard Deviation 17.68
|
-5.8 mmHg
Standard Deviation 18.68
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 7 Observed
|
113.9 mmHg
Standard Deviation 17.10
|
113.9 mmHg
Standard Deviation 14.96
|
110.1 mmHg
Standard Deviation 17.41
|
110.1 mmHg
Standard Deviation 15.32
|
112.7 mmHg
Standard Deviation 13.26
|
114.6 mmHg
Standard Deviation 16.42
|
111.6 mmHg
Standard Deviation 14.00
|
118.0 mmHg
Standard Deviation 13.00
|
116.6 mmHg
Standard Deviation 15.53
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 7 Change
|
-8.7 mmHg
Standard Deviation 17.74
|
-8.2 mmHg
Standard Deviation 16.40
|
-8.8 mmHg
Standard Deviation 16.55
|
-9.6 mmHg
Standard Deviation 17.71
|
-6.8 mmHg
Standard Deviation 14.10
|
-4.6 mmHg
Standard Deviation 17.96
|
-7.3 mmHg
Standard Deviation 17.01
|
-4.6 mmHg
Standard Deviation 15.53
|
-5.8 mmHg
Standard Deviation 19.56
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 8 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
117.8 mmHg
Standard Deviation 11.13
|
117.6 mmHg
Standard Deviation 13.94
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 8 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.8 mmHg
Standard Deviation 13.53
|
-2.5 mmHg
Standard Deviation 18.18
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 9 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
119.4 mmHg
Standard Deviation 10.62
|
119.5 mmHg
Standard Deviation 17.05
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 9 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.8 mmHg
Standard Deviation 13.27
|
-0.9 mmHg
Standard Deviation 21.35
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 10 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
122.3 mmHg
Standard Deviation 14.78
|
121.9 mmHg
Standard Deviation 18.78
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 10 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.6 mmHg
Standard Deviation 15.46
|
1.6 mmHg
Standard Deviation 22.89
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 11 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
123.7 mmHg
Standard Deviation 14.91
|
123.2 mmHg
Standard Deviation 14.43
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 11 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.0 mmHg
Standard Deviation 16.20
|
1.8 mmHg
Standard Deviation 18.90
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 12 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
124.3 mmHg
Standard Deviation 11.19
|
118.4 mmHg
Standard Deviation 14.06
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 12 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.0 mmHg
Standard Deviation 12.76
|
-4.1 mmHg
Standard Deviation 16.91
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 13 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
122.7 mmHg
Standard Deviation 11.77
|
125.1 mmHg
Standard Deviation 12.25
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 13 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.0 mmHg
Standard Deviation 14.58
|
3.5 mmHg
Standard Deviation 16.41
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 14 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
128.8 mmHg
Standard Deviation 9.89
|
—
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 14 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.8 mmHg
Standard Deviation 9.92
|
—
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 1 Observed
|
120.4 mmHg
Standard Deviation 13.94
|
105.7 mmHg
Standard Deviation 16.70
|
107.9 mmHg
Standard Deviation 16.43
|
106.7 mmHg
Standard Deviation 15.66
|
108.2 mmHg
Standard Deviation 16.37
|
108.7 mmHg
Standard Deviation 15.75
|
109.0 mmHg
Standard Deviation 16.93
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 1 Change
|
—
|
-16.8 mmHg
Standard Deviation 16.80
|
-14.3 mmHg
Standard Deviation 15.95
|
-15.8 mmHg
Standard Deviation 16.48
|
-14.7 mmHg
Standard Deviation 15.80
|
-13.9 mmHg
Standard Deviation 17.31
|
-13.6 mmHg
Standard Deviation 17.74
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 2 Observed
|
112.4 mmHg
Standard Deviation 15.85
|
108.5 mmHg
Standard Deviation 15.94
|
108.0 mmHg
Standard Deviation 15.06
|
108.6 mmHg
Standard Deviation 16.90
|
109.8 mmHg
Standard Deviation 16.22
|
110.4 mmHg
Standard Deviation 17.70
|
110.7 mmHg
Standard Deviation 16.07
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Day 2 Change
|
-10.0 mmHg
Standard Deviation 16.32
|
-14.0 mmHg
Standard Deviation 17.24
|
-14.7 mmHg
Standard Deviation 16.29
|
-14.1 mmHg
Standard Deviation 17.11
|
-13.0 mmHg
Standard Deviation 17.07
|
-12.2 mmHg
Standard Deviation 17.69
|
-11.9 mmHg
Standard Deviation 16.91
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 1 Observed
|
78.3 mmHg
Standard Deviation 8.89
|
69.4 mmHg
Standard Deviation 10.95
|
69.3 mmHg
Standard Deviation 10.34
|
70.8 mmHg
Standard Deviation 11.13
|
71.5 mmHg
Standard Deviation 10.76
|
73.5 mmHg
Standard Deviation 12.18
|
72.8 mmHg
Standard Deviation 12.26
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 1 Change
|
NA mmHg
Standard Deviation NA
Prior to first dose.
|
-7.8 mmHg
Standard Deviation 10.78
|
-7.9 mmHg
Standard Deviation 9.88
|
-6.3 mmHg
Standard Deviation 11.49
|
-5.7 mmHg
Standard Deviation 10.80
|
-3.7 mmHg
Standard Deviation 12.52
|
-4.3 mmHg
Standard Deviation 12.55
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 2 Observed
|
73.8 mmHg
Standard Deviation 10.49
|
72.2 mmHg
Standard Deviation 10.89
|
72.2 mmHg
Standard Deviation 10.20
|
73.4 mmHg
Standard Deviation 11.53
|
73.7 mmHg
Standard Deviation 12.08
|
75.4 mmHg
Standard Deviation 11.67
|
74.0 mmHg
Standard Deviation 11.44
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 2 Change
|
-3.3 mmHg
Standard Deviation 10.73
|
-4.9 mmHg
Standard Deviation 11.17
|
-5.0 mmHg
Standard Deviation 10.61
|
-3.8 mmHg
Standard Deviation 11.38
|
-3.4 mmHg
Standard Deviation 12.04
|
-1.8 mmHg
Standard Deviation 12.19
|
-3.3 mmHg
Standard Deviation 12.11
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 3 Observed
|
73.7 mmHg
Standard Deviation 11.05
|
73.2 mmHg
Standard Deviation 10.59
|
71.4 mmHg
Standard Deviation 10.05
|
73.0 mmHg
Standard Deviation 10.48
|
72.9 mmHg
Standard Deviation 10.64
|
73.2 mmHg
Standard Deviation 11.32
|
73.5 mmHg
Standard Deviation 11.08
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 3 Change
|
-3.6 mmHg
Standard Deviation 11.60
|
-4.0 mmHg
Standard Deviation 10.97
|
-5.8 mmHg
Standard Deviation 10.88
|
-4.1 mmHg
Standard Deviation 10.32
|
-4.3 mmHg
Standard Deviation 10.56
|
-4.0 mmHg
Standard Deviation 11.41
|
-3.8 mmHg
Standard Deviation 11.37
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 4 Observed
|
73.9 mmHg
Standard Deviation 10.55
|
71.4 mmHg
Standard Deviation 10.28
|
70.9 mmHg
Standard Deviation 11.11
|
74.7 mmHg
Standard Deviation 10.39
|
73.7 mmHg
Standard Deviation 10.10
|
74.0 mmHg
Standard Deviation 10.95
|
73.4 mmHg
Standard Deviation 9.78
|
75.0 mmHg
Standard Deviation 8.57
|
71.7 mmHg
Standard Deviation 8.53
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 4 Change
|
-3.2 mmHg
Standard Deviation 11.06
|
-5.7 mmHg
Standard Deviation 10.75
|
-6.4 mmHg
Standard Deviation 10.48
|
-2.6 mmHg
Standard Deviation 10.27
|
-3.3 mmHg
Standard Deviation 9.74
|
-3.1 mmHg
Standard Deviation 11.75
|
-3.6 mmHg
Standard Deviation 10.51
|
-3.0 mmHg
Standard Deviation 10.65
|
-6.1 mmHg
Standard Deviation 10.68
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 5 Observed
|
73.2 mmHg
Standard Deviation 10.42
|
71.5 mmHg
Standard Deviation 10.25
|
71.7 mmHg
Standard Deviation 10.38
|
72.7 mmHg
Standard Deviation 10.58
|
71.8 mmHg
Standard Deviation 10.14
|
73.1 mmHg
Standard Deviation 9.97
|
72.3 mmHg
Standard Deviation 10.44
|
72.6 mmHg
Standard Deviation 9.99
|
72.8 mmHg
Standard Deviation 10.67
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 5 Change
|
-3.8 mmHg
Standard Deviation 11.17
|
-5.4 mmHg
Standard Deviation 11.75
|
-5.1 mmHg
Standard Deviation 10.59
|
-4.2 mmHg
Standard Deviation 10.38
|
-5.0 mmHg
Standard Deviation 10.79
|
-3.7 mmHg
Standard Deviation 10.77
|
-4.7 mmHg
Standard Deviation 10.56
|
-5.6 mmHg
Standard Deviation 11.18
|
-6.0 mmHg
Standard Deviation 12.01
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 6 Observed
|
72.2 mmHg
Standard Deviation 10.33
|
69.8 mmHg
Standard Deviation 10.46
|
70.8 mmHg
Standard Deviation 10.81
|
72.2 mmHg
Standard Deviation 10.08
|
72.6 mmHg
Standard Deviation 11.02
|
72.8 mmHg
Standard Deviation 11.35
|
72.0 mmHg
Standard Deviation 11.29
|
74.2 mmHg
Standard Deviation 11.25
|
76.8 mmHg
Standard Deviation 9.99
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 6 Change
|
-4.6 mmHg
Standard Deviation 9.87
|
-7.0 mmHg
Standard Deviation 10.86
|
-6.0 mmHg
Standard Deviation 11.42
|
-4.6 mmHg
Standard Deviation 10.46
|
-4.3 mmHg
Standard Deviation 10.77
|
-4.0 mmHg
Standard Deviation 11.05
|
-4.9 mmHg
Standard Deviation 11.51
|
-3.9 mmHg
Standard Deviation 12.17
|
-1.4 mmHg
Standard Deviation 12.90
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 7 Observed
|
72.9 mmHg
Standard Deviation 10.63
|
74.3 mmHg
Standard Deviation 9.90
|
71.5 mmHg
Standard Deviation 11.18
|
70.2 mmHg
Standard Deviation 10.40
|
70.0 mmHg
Standard Deviation 9.09
|
73.1 mmHg
Standard Deviation 9.62
|
69.8 mmHg
Standard Deviation 8.04
|
76.1 mmHg
Standard Deviation 9.30
|
71.8 mmHg
Standard Deviation 8.90
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 7 Change
|
-3.6 mmHg
Standard Deviation 11.56
|
-3.5 mmHg
Standard Deviation 10.59
|
-4.8 mmHg
Standard Deviation 12.01
|
-6.9 mmHg
Standard Deviation 10.96
|
-7.6 mmHg
Standard Deviation 10.25
|
-4.5 mmHg
Standard Deviation 10.21
|
-7.5 mmHg
Standard Deviation 12.94
|
-2.6 mmHg
Standard Deviation 11.32
|
-7.6 mmHg
Standard Deviation 14.12
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 14 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.5 mmHg
Standard Deviation 9.72
|
—
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 8 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
73.5 mmHg
Standard Deviation 9.23
|
73.9 mmHg
Standard Deviation 11.18
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 8 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-4.1 mmHg
Standard Deviation 10.98
|
-3.5 mmHg
Standard Deviation 13.10
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 9 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
75.5 mmHg
Standard Deviation 9.38
|
74.0 mmHg
Standard Deviation 11.92
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 9 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-1.7 mmHg
Standard Deviation 10.71
|
-3.5 mmHg
Standard Deviation 12.63
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 10 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
74.6 mmHg
Standard Deviation 9.44
|
75.8 mmHg
Standard Deviation 12.46
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 10 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.4 mmHg
Standard Deviation 9.31
|
-1.2 mmHg
Standard Deviation 12.34
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 11 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
75.7 mmHg
Standard Deviation 10.37
|
76.3 mmHg
Standard Deviation 8.99
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 11 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.9 mmHg
Standard Deviation 11.57
|
-0.4 mmHg
Standard Deviation 10.87
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 12 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
77.3 mmHg
Standard Deviation 8.01
|
76.6 mmHg
Standard Deviation 8.26
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 12 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.6 mmHg
Standard Deviation 10.39
|
-0.5 mmHg
Standard Deviation 9.47
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 13 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
77.2 mmHg
Standard Deviation 8.22
|
77.9 mmHg
Standard Deviation 8.98
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 13 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.3 mmHg
Standard Deviation 10.94
|
2.0 mmHg
Standard Deviation 13.71
|
|
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Day 14 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
78.4 mmHg
Standard Deviation 7.81
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 3 Change
|
-6.2 mmHg
Standard Deviation 12.37
|
-9.4 mmHg
Standard Deviation 13.09
|
-10.0 mmHg
Standard Deviation 11.74
|
-10.1 mmHg
Standard Deviation 11.91
|
-9.3 mmHg
Standard Deviation 12.00
|
-8.8 mmHg
Standard Deviation 11.91
|
-8.7 mmHg
Standard Deviation 11.78
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 4 Observed
|
73.2 mmHg
Standard Deviation 11.80
|
70.6 mmHg
Standard Deviation 11.11
|
71.2 mmHg
Standard Deviation 11.12
|
71.5 mmHg
Standard Deviation 10.98
|
72.2 mmHg
Standard Deviation 10.59
|
71.2 mmHg
Standard Deviation 11.09
|
71.8 mmHg
Standard Deviation 10.14
|
75.7 mmHg
Standard Deviation 10.45
|
70.1 mmHg
Standard Deviation 10.26
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 4 Change
|
-7.0 mmHg
Standard Deviation 12.08
|
-9.4 mmHg
Standard Deviation 11.90
|
-9.2 mmHg
Standard Deviation 11.96
|
-8.9 mmHg
Standard Deviation 12.91
|
-8.0 mmHg
Standard Deviation 11.71
|
-9.0 mmHg
Standard Deviation 12.64
|
-8.2 mmHg
Standard Deviation 11.46
|
-4.5 mmHg
Standard Deviation 13.21
|
-10.0 mmHg
Standard Deviation 11.81
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 5 Observed
|
72.4 mmHg
Standard Deviation 10.04
|
70.0 mmHg
Standard Deviation 10.46
|
70.7 mmHg
Standard Deviation 10.76
|
70.3 mmHg
Standard Deviation 10.99
|
71.1 mmHg
Standard Deviation 11.38
|
70.2 mmHg
Standard Deviation 11.20
|
71.1 mmHg
Standard Deviation 10.94
|
74.8 mmHg
Standard Deviation 9.79
|
74.5 mmHg
Standard Deviation 10.44
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 5 Change
|
-7.6 mmHg
Standard Deviation 11.99
|
-10.0 mmHg
Standard Deviation 11.47
|
-9.2 mmHg
Standard Deviation 12.07
|
-9.6 mmHg
Standard Deviation 13.00
|
-8.7 mmHg
Standard Deviation 12.76
|
-9.8 mmHg
Standard Deviation 12.01
|
-9.0 mmHg
Standard Deviation 11.39
|
-5.5 mmHg
Standard Deviation 10.70
|
-6.3 mmHg
Standard Deviation 12.07
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 6 Observed
|
72.9 mmHg
Standard Deviation 10.11
|
69.3 mmHg
Standard Deviation 10.11
|
71.1 mmHg
Standard Deviation 10.70
|
70.2 mmHg
Standard Deviation 11.15
|
71.4 mmHg
Standard Deviation 11.43
|
72.1 mmHg
Standard Deviation 12.37
|
72.5 mmHg
Standard Deviation 11.07
|
74.1 mmHg
Standard Deviation 12.33
|
73.2 mmHg
Standard Deviation 11.31
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 6 Change
|
-7.1 mmHg
Standard Deviation 11.40
|
-10.7 mmHg
Standard Deviation 12.20
|
-8.9 mmHg
Standard Deviation 11.60
|
-9.8 mmHg
Standard Deviation 12.77
|
-8.6 mmHg
Standard Deviation 12.26
|
-7.9 mmHg
Standard Deviation 13.33
|
-7.5 mmHg
Standard Deviation 11.88
|
-6.1 mmHg
Standard Deviation 13.61
|
-6.8 mmHg
Standard Deviation 14.08
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 7 Observed
|
73.6 mmHg
Standard Deviation 11.16
|
73.2 mmHg
Standard Deviation 11.07
|
70.3 mmHg
Standard Deviation 11.17
|
71.3 mmHg
Standard Deviation 11.69
|
70.4 mmHg
Standard Deviation 11.25
|
72.5 mmHg
Standard Deviation 10.89
|
69.0 mmHg
Standard Deviation 8.93
|
77.1 mmHg
Standard Deviation 11.43
|
70.8 mmHg
Standard Deviation 11.27
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 7 Change
|
-6.2 mmHg
Standard Deviation 12.37
|
-7.4 mmHg
Standard Deviation 11.17
|
-9.5 mmHg
Standard Deviation 9.83
|
-9.7 mmHg
Standard Deviation 12.29
|
-10.8 mmHg
Standard Deviation 11.06
|
-8.5 mmHg
Standard Deviation 12.94
|
-11.8 mmHg
Standard Deviation 11.89
|
-3.3 mmHg
Standard Deviation 12.24
|
-10.4 mmHg
Standard Deviation 15.57
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 8 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
74.6 mmHg
Standard Deviation 9.22
|
74.5 mmHg
Standard Deviation 13.60
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 8 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-5.8 mmHg
Standard Deviation 10.46
|
-6.2 mmHg
Standard Deviation 14.23
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 9 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
78.4 mmHg
Standard Deviation 9.63
|
76.5 mmHg
Standard Deviation 14.02
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 9 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-1.8 mmHg
Standard Deviation 10.89
|
-4.2 mmHg
Standard Deviation 13.95
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 10 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
76.9 mmHg
Standard Deviation 10.41
|
75.9 mmHg
Standard Deviation 11.86
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 10 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-3.2 mmHg
Standard Deviation 10.32
|
-4.5 mmHg
Standard Deviation 12.68
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 11 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
78.1 mmHg
Standard Deviation 11.01
|
76.0 mmHg
Standard Deviation 9.55
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 11 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-1.7 mmHg
Standard Deviation 10.96
|
-3.9 mmHg
Standard Deviation 9.81
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 12 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
80.0 mmHg
Standard Deviation 8.12
|
78.7 mmHg
Standard Deviation 9.55
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 12 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.3 mmHg
Standard Deviation 8.62
|
-1.6 mmHg
Standard Deviation 11.95
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 13 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
83.6 mmHg
Standard Deviation 8.38
|
80.8 mmHg
Standard Deviation 8.69
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 13 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.5 mmHg
Standard Deviation 10.29
|
1.1 mmHg
Standard Deviation 12.01
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 14 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
84.8 mmHg
Standard Deviation 8.53
|
—
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 14 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.5 mmHg
Standard Deviation 9.72
|
—
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 1 Observed
|
79.8 mmHg
Standard Deviation 8.65
|
68.8 mmHg
Standard Deviation 11.34
|
70.3 mmHg
Standard Deviation 11.03
|
69.8 mmHg
Standard Deviation 11.87
|
70.7 mmHg
Standard Deviation 11.25
|
71.0 mmHg
Standard Deviation 11.12
|
70.4 mmHg
Standard Deviation 11.68
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 1 Change
|
—
|
-11.1 mmHg
Standard Deviation 11.58
|
-9.5 mmHg
Standard Deviation 11.26
|
-10.0 mmHg
Standard Deviation 12.57
|
-9.4 mmHg
Standard Deviation 11.73
|
-8.9 mmHg
Standard Deviation 12.71
|
-9.6 mmHg
Standard Deviation 12.92
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 2 Observed
|
73.4 mmHg
Standard Deviation 11.02
|
70.7 mmHg
Standard Deviation 11.20
|
71.0 mmHg
Standard Deviation 11.48
|
71.6 mmHg
Standard Deviation 11.85
|
72.2 mmHg
Standard Deviation 11.78
|
72.3 mmHg
Standard Deviation 12.27
|
71.8 mmHg
Standard Deviation 11.52
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 2 Change
|
-6.5 mmHg
Standard Deviation 11.83
|
-9.4 mmHg
Standard Deviation 12.26
|
-9.1 mmHg
Standard Deviation 12.74
|
-8.5 mmHg
Standard Deviation 12.48
|
-7.9 mmHg
Standard Deviation 13.00
|
-7.9 mmHg
Standard Deviation 13.44
|
-8.4 mmHg
Standard Deviation 13.05
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Day 3 Observed
|
74.0 mmHg
Standard Deviation 12.03
|
70.6 mmHg
Standard Deviation 11.90
|
70.0 mmHg
Standard Deviation 10.53
|
70.0 mmHg
Standard Deviation 10.62
|
70.8 mmHg
Standard Deviation 10.77
|
71.3 mmHg
Standard Deviation 10.69
|
71.5 mmHg
Standard Deviation 10.90
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 2 Observed
|
70.2 beats per minute (bpm)
Standard Deviation 12.70
|
68.8 beats per minute (bpm)
Standard Deviation 12.36
|
69.4 beats per minute (bpm)
Standard Deviation 11.57
|
66.8 beats per minute (bpm)
Standard Deviation 12.65
|
68.7 beats per minute (bpm)
Standard Deviation 12.11
|
65.9 beats per minute (bpm)
Standard Deviation 12.41
|
66.4 beats per minute (bpm)
Standard Deviation 12.55
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 2 Change
|
-4.7 beats per minute (bpm)
Standard Deviation 14.21
|
-5.9 beats per minute (bpm)
Standard Deviation 14.63
|
-5.4 beats per minute (bpm)
Standard Deviation 13.64
|
-8.0 beats per minute (bpm)
Standard Deviation 14.53
|
-6.2 beats per minute (bpm)
Standard Deviation 13.75
|
-9.1 beats per minute (bpm)
Standard Deviation 14.30
|
-8.6 beats per minute (bpm)
Standard Deviation 14.30
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 3 Observed
|
213 beats per minute (bpm)
Standard Deviation 70.0
|
67.5 beats per minute (bpm)
Standard Deviation 12.97
|
68.7 beats per minute (bpm)
Standard Deviation 11.57
|
66.6 beats per minute (bpm)
Standard Deviation 12.03
|
68.3 beats per minute (bpm)
Standard Deviation 12.23
|
65.9 beats per minute (bpm)
Standard Deviation 11.68
|
67.4 beats per minute (bpm)
Standard Deviation 12.01
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 1 Observed
|
73.3 beats per minute (bpm)
Standard Deviation 10.89
|
68.8 beats per minute (bpm)
Standard Deviation 11.92
|
69.2 beats per minute (bpm)
Standard Deviation 11.08
|
69.9 beats per minute (bpm)
Standard Deviation 12.57
|
70.5 beats per minute (bpm)
Standard Deviation 12.28
|
67.6 beats per minute (bpm)
Standard Deviation 12.55
|
67.7 beats per minute (bpm)
Standard Deviation 12.08
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 1 Change
|
NA beats per minute (bpm)
Standard Deviation NA
Prior to first dose.
|
-6.1 beats per minute (bpm)
Standard Deviation 12.75
|
-5.7 beats per minute (bpm)
Standard Deviation 12.11
|
-4.9 beats per minute (bpm)
Standard Deviation 13.47
|
-4.3 beats per minute (bpm)
Standard Deviation 13.63
|
-7.3 beats per minute (bpm)
Standard Deviation 13.59
|
-7.0 beats per minute (bpm)
Standard Deviation 12.82
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 3 Change
|
-5.0 beats per minute (bpm)
Standard Deviation 15.10
|
-7.5 beats per minute (bpm)
Standard Deviation 15.52
|
-6.4 beats per minute (bpm)
Standard Deviation 14.42
|
-8.5 beats per minute (bpm)
Standard Deviation 14.77
|
-6.8 beats per minute (bpm)
Standard Deviation 14.26
|
-9.2 beats per minute (bpm)
Standard Deviation 14.25
|
-7.8 beats per minute (bpm)
Standard Deviation 13.70
|
—
|
—
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 4 Observed
|
70.1 beats per minute (bpm)
Standard Deviation 13.60
|
68.3 beats per minute (bpm)
Standard Deviation 12.46
|
70.6 beats per minute (bpm)
Standard Deviation 12.98
|
67.8 beats per minute (bpm)
Standard Deviation 13.00
|
70.0 beats per minute (bpm)
Standard Deviation 12.01
|
67.8 beats per minute (bpm)
Standard Deviation 13.80
|
69.9 beats per minute (bpm)
Standard Deviation 12.80
|
70.6 beats per minute (bpm)
Standard Deviation 11.83
|
72.4 beats per minute (bpm)
Standard Deviation 12.46
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 4 Change
|
-5.0 beats per minute (bpm)
Standard Deviation 16.11
|
-6.8 beats per minute (bpm)
Standard Deviation 15.56
|
-4.5 beats per minute (bpm)
Standard Deviation 15.43
|
-7.3 beats per minute (bpm)
Standard Deviation 15.44
|
-5.0 beats per minute (bpm)
Standard Deviation 15.35
|
-6.8 beats per minute (bpm)
Standard Deviation 16.59
|
-4.5 beats per minute (bpm)
Standard Deviation 14.74
|
-5.2 beats per minute (bpm)
Standard Deviation 13.76
|
-3.3 beats per minute (bpm)
Standard Deviation 13.25
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 5 Observed
|
70.9 beats per minute (bpm)
Standard Deviation 13.70
|
69.1 beats per minute (bpm)
Standard Deviation 11.03
|
71.4 beats per minute (bpm)
Standard Deviation 11.78
|
69.0 beats per minute (bpm)
Standard Deviation 13.35
|
68.7 beats per minute (bpm)
Standard Deviation 11.08
|
68.3 beats per minute (bpm)
Standard Deviation 12.84
|
70.0 beats per minute (bpm)
Standard Deviation 11.20
|
76.3 beats per minute (bpm)
Standard Deviation 13.49
|
73.3 beats per minute (bpm)
Standard Deviation 11.44
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 5 Change
|
-3.4 beats per minute (bpm)
Standard Deviation 16.28
|
-5.3 beats per minute (bpm)
Standard Deviation 13.57
|
-2.8 beats per minute (bpm)
Standard Deviation 13.92
|
-5.2 beats per minute (bpm)
Standard Deviation 15.23
|
-5.5 beats per minute (bpm)
Standard Deviation 12.29
|
-6.0 beats per minute (bpm)
Standard Deviation 15.26
|
-4.4 beats per minute (bpm)
Standard Deviation 13.53
|
-0.3 beats per minute (bpm)
Standard Deviation 15.14
|
-3.2 beats per minute (bpm)
Standard Deviation 13.70
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 6 Observed
|
70.5 beats per minute (bpm)
Standard Deviation 11.24
|
69.8 beats per minute (bpm)
Standard Deviation 12.46
|
70.6 beats per minute (bpm)
Standard Deviation 12.24
|
68.6 beats per minute (bpm)
Standard Deviation 11.43
|
69.7 beats per minute (bpm)
Standard Deviation 10.67
|
68.9 beats per minute (bpm)
Standard Deviation 13.05
|
71.2 beats per minute (bpm)
Standard Deviation 12.43
|
75.2 beats per minute (bpm)
Standard Deviation 12.24
|
74.8 beats per minute (bpm)
Standard Deviation 13.10
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 6 Change
|
-3.6 beats per minute (bpm)
Standard Deviation 14.98
|
-4.1 beats per minute (bpm)
Standard Deviation 14.44
|
-3.3 beats per minute (bpm)
Standard Deviation 13.62
|
-5.3 beats per minute (bpm)
Standard Deviation 14.37
|
-4.3 beats per minute (bpm)
Standard Deviation 12.88
|
-5.1 beats per minute (bpm)
Standard Deviation 14.79
|
-2.8 beats per minute (bpm)
Standard Deviation 13.55
|
-1.6 beats per minute (bpm)
Standard Deviation 14.82
|
-1.6 beats per minute (bpm)
Standard Deviation 14.29
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 7 Observed
|
73.2 beats per minute (bpm)
Standard Deviation 13.34
|
73.9 beats per minute (bpm)
Standard Deviation 11.70
|
73.6 beats per minute (bpm)
Standard Deviation 11.55
|
73.0 beats per minute (bpm)
Standard Deviation 12.53
|
73.6 beats per minute (bpm)
Standard Deviation 11.74
|
67.4 beats per minute (bpm)
Standard Deviation 13.44
|
69.8 beats per minute (bpm)
Standard Deviation 11.59
|
73.6 beats per minute (bpm)
Standard Deviation 11.46
|
67.1 beats per minute (bpm)
Standard Deviation 8.84
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 7 Change
|
-1.1 beats per minute (bpm)
Standard Deviation 16.86
|
0.0 beats per minute (bpm)
Standard Deviation 13.60
|
-3.1 beats per minute (bpm)
Standard Deviation 13.15
|
-3.8 beats per minute (bpm)
Standard Deviation 12.93
|
-3.4 beats per minute (bpm)
Standard Deviation 11.72
|
-9.5 beats per minute (bpm)
Standard Deviation 13.96
|
24 beats per minute (bpm)
Standard Deviation 13.29
|
-3.4 beats per minute (bpm)
Standard Deviation 15.07
|
-7.7 beats per minute (bpm)
Standard Deviation 10.63
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 8 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
77.7 beats per minute (bpm)
Standard Deviation 12.71
|
72.6 beats per minute (bpm)
Standard Deviation 13.45
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 8 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.6 beats per minute (bpm)
Standard Deviation 15.25
|
-3.8 beats per minute (bpm)
Standard Deviation 13.48
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 9 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
79.6 beats per minute (bpm)
Standard Deviation 10.77
|
75.1 beats per minute (bpm)
Standard Deviation 11.19
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 9 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.8 beats per minute (bpm)
Standard Deviation 11.80
|
-1.7 beats per minute (bpm)
Standard Deviation 11.18
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 10 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
80.0 beats per minute (bpm)
Standard Deviation 13.29
|
77.9 beats per minute (bpm)
Standard Deviation 16.42
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 10 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.2 beats per minute (bpm)
Standard Deviation 14.82
|
1.1 beats per minute (bpm)
Standard Deviation 16.97
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 11 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
79.3 beats per minute (bpm)
Standard Deviation 13.93
|
74.5 beats per minute (bpm)
Standard Deviation 12.49
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 11 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.2 beats per minute (bpm)
Standard Deviation 13.40
|
-1.4 beats per minute (bpm)
Standard Deviation 12.92
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 12 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
79.7 beats per minute (bpm)
Standard Deviation 11.89
|
72.3 beats per minute (bpm)
Standard Deviation 11.68
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 12 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 beats per minute (bpm)
Standard Deviation 14.22
|
-3.6 beats per minute (bpm)
Standard Deviation 12.29
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 13 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
76.6 beats per minute (bpm)
Standard Deviation 13.20
|
75.5 beats per minute (bpm)
Standard Deviation 13.61
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 13 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.4 beats per minute (bpm)
Standard Deviation 14.79
|
0.8 beats per minute (bpm)
Standard Deviation 11.75
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 14 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
76.4 beats per minute (bpm)
Standard Deviation 11.66
|
—
|
|
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Day 14 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.4 beats per minute (bpm)
Standard Deviation 14.27
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 1 Observed
|
82.8 beats per minute (bpm)
Standard Deviation 13.74
|
79.6 beats per minute (bpm)
Standard Deviation 14.29
|
80.1 beats per minute (bpm)
Standard Deviation 13.72
|
81.3 beats per minute (bpm)
Standard Deviation 14.42
|
81.2 beats per minute (bpm)
Standard Deviation 14.17
|
78.9 beats per minute (bpm)
Standard Deviation 14.14
|
79.4 beats per minute (bpm)
Standard Deviation 14.03
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 1 Change
|
NA beats per minute (bpm)
Standard Deviation NA
Prior to first dose.
|
-1.8 beats per minute (bpm)
Standard Deviation 15.18
|
-1.3 beats per minute (bpm)
Standard Deviation 14.38
|
0.0 beats per minute (bpm)
Standard Deviation 16.41
|
-0.1 beats per minute (bpm)
Standard Deviation 15.89
|
-2.5 beats per minute (bpm)
Standard Deviation 16.25
|
-1.8 beats per minute (bpm)
Standard Deviation 16.00
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 2 Observed
|
82.4 beats per minute (bpm)
Standard Deviation 15.13
|
80.6 beats per minute (bpm)
Standard Deviation 15.19
|
81.1 beats per minute (bpm)
Standard Deviation 13.74
|
80.5 beats per minute (bpm)
Standard Deviation 14.44
|
80.8 beats per minute (bpm)
Standard Deviation 14.46
|
78.0 beats per minute (bpm)
Standard Deviation 14.67
|
78.4 beats per minute (bpm)
Standard Deviation 13.95
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 2 Change
|
1.0 beats per minute (bpm)
Standard Deviation 16.81
|
-0.5 beats per minute (bpm)
Standard Deviation 17.61
|
0.0 beats per minute (bpm)
Standard Deviation 16.22
|
-0.6 beats per minute (bpm)
Standard Deviation 15.44
|
-0.4 beats per minute (bpm)
Standard Deviation 16.00
|
-3.3 beats per minute (bpm)
Standard Deviation 16.49
|
-3.0 beats per minute (bpm)
Standard Deviation 16.62
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 3 Observed
|
81.1 beats per minute (bpm)
Standard Deviation 14.82
|
79.0 beats per minute (bpm)
Standard Deviation 14.24
|
80.0 beats per minute (bpm)
Standard Deviation 14.67
|
78.1 beats per minute (bpm)
Standard Deviation 15.09
|
79.1 beats per minute (bpm)
Standard Deviation 15.36
|
76.4 beats per minute (bpm)
Standard Deviation 13.75
|
78.3 beats per minute (bpm)
Standard Deviation 13.92
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 3 Change
|
-0.2 beats per minute (bpm)
Standard Deviation 16.77
|
-2.6 beats per minute (bpm)
Standard Deviation 16.59
|
-1.5 beats per minute (bpm)
Standard Deviation 15.95
|
-3.3 beats per minute (bpm)
Standard Deviation 17.08
|
-2.3 beats per minute (bpm)
Standard Deviation 16.27
|
-5.0 beats per minute (bpm)
Standard Deviation 16.31
|
-3.2 beats per minute (bpm)
Standard Deviation 16.32
|
—
|
—
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 4 Observed
|
81.2 beats per minute (bpm)
Standard Deviation 14.93
|
80.1 beats per minute (bpm)
Standard Deviation 14.67
|
81.5 beats per minute (bpm)
Standard Deviation 15.40
|
79.9 beats per minute (bpm)
Standard Deviation 15.42
|
80.8 beats per minute (bpm)
Standard Deviation 16.34
|
78.2 beats per minute (bpm)
Standard Deviation 15.52
|
80.4 beats per minute (bpm)
Standard Deviation 16.16
|
82.0 beats per minute (bpm)
Standard Deviation 11.75
|
83.3 beats per minute (bpm)
Standard Deviation 15.43
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 4 Change
|
-0.2 beats per minute (bpm)
Standard Deviation 16.09
|
-1.3 beats per minute (bpm)
Standard Deviation 16.36
|
0.0 beats per minute (bpm)
Standard Deviation 16.85
|
-1.5 beats per minute (bpm)
Standard Deviation 17.75
|
-0.7 beats per minute (bpm)
Standard Deviation 18.62
|
-2.7 beats per minute (bpm)
Standard Deviation 17.29
|
-0.2 beats per minute (bpm)
Standard Deviation 17.49
|
0.9 beats per minute (bpm)
Standard Deviation 15.06
|
2.1 beats per minute (bpm)
Standard Deviation 18.73
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 5 Observed
|
83.1 beats per minute (bpm)
Standard Deviation 16.31
|
81.0 beats per minute (bpm)
Standard Deviation 14.06
|
82.3 beats per minute (bpm)
Standard Deviation 15.43
|
84.7 beats per minute (bpm)
Standard Deviation 51.39
|
80.2 beats per minute (bpm)
Standard Deviation 14.86
|
79.5 beats per minute (bpm)
Standard Deviation 14.08
|
80.6 beats per minute (bpm)
Standard Deviation 14.74
|
85.2 beats per minute (bpm)
Standard Deviation 15.23
|
80.8 beats per minute (bpm)
Standard Deviation 14.81
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 5 Change
|
2.4 beats per minute (bpm)
Standard Deviation 18.58
|
0.3 beats per minute (bpm)
Standard Deviation 15.33
|
1.6 beats per minute (bpm)
Standard Deviation 16.77
|
4.2 beats per minute (bpm)
Standard Deviation 50.96
|
-0.4 beats per minute (bpm)
Standard Deviation 14.80
|
-1.2 beats per minute (bpm)
Standard Deviation 15.68
|
-0.1 beats per minute (bpm)
Standard Deviation 16.33
|
2.8 beats per minute (bpm)
Standard Deviation 16.75
|
-1.7 beats per minute (bpm)
Standard Deviation 15.90
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 6 Observed
|
81.7 beats per minute (bpm)
Standard Deviation 14.96
|
79.9 beats per minute (bpm)
Standard Deviation 14.89
|
81.8 beats per minute (bpm)
Standard Deviation 14.90
|
79.5 beats per minute (bpm)
Standard Deviation 14.00
|
81.5 beats per minute (bpm)
Standard Deviation 13.93
|
80.9 beats per minute (bpm)
Standard Deviation 14.54
|
80.9 beats per minute (bpm)
Standard Deviation 15.77
|
86.4 beats per minute (bpm)
Standard Deviation 15.08
|
84.8 beats per minute (bpm)
Standard Deviation 14.77
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 6 Change
|
1.4 beats per minute (bpm)
Standard Deviation 16.05
|
-0.5 beats per minute (bpm)
Standard Deviation 16.33
|
1.4 beats per minute (bpm)
Standard Deviation 15.99
|
-0.9 beats per minute (bpm)
Standard Deviation 16.16
|
1.0 beats per minute (bpm)
Standard Deviation 15.28
|
0.4 beats per minute (bpm)
Standard Deviation 15.68
|
0.4 beats per minute (bpm)
Standard Deviation 16.97
|
2.6 beats per minute (bpm)
Standard Deviation 16.42
|
1.6 beats per minute (bpm)
Standard Deviation 15.33
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 7 Observed
|
84.5 beats per minute (bpm)
Standard Deviation 15.44
|
80.3 beats per minute (bpm)
Standard Deviation 12.44
|
83.4 beats per minute (bpm)
Standard Deviation 13.89
|
79.0 beats per minute (bpm)
Standard Deviation 13.45
|
80.0 beats per minute (bpm)
Standard Deviation 14.40
|
75.1 beats per minute (bpm)
Standard Deviation 13.69
|
74.3 beats per minute (bpm)
Standard Deviation 12.41
|
83.2 beats per minute (bpm)
Standard Deviation 13.11
|
76.9 beats per minute (bpm)
Standard Deviation 11.29
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 7 Change
|
3.5 beats per minute (bpm)
Standard Deviation 18.07
|
0.2 beats per minute (bpm)
Standard Deviation 14.16
|
-0.5 beats per minute (bpm)
Standard Deviation 16.23
|
-4.9 beats per minute (bpm)
Standard Deviation 14.53
|
-3.6 beats per minute (bpm)
Standard Deviation 16.19
|
-8.6 beats per minute (bpm)
Standard Deviation 17.80
|
-9.7 beats per minute (bpm)
Standard Deviation 16.75
|
-0.5 beats per minute (bpm)
Standard Deviation 16.99
|
-4.3 beats per minute (bpm)
Standard Deviation 12.54
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 8 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
85.3 beats per minute (bpm)
Standard Deviation 15.03
|
80.7 beats per minute (bpm)
Standard Deviation 14.61
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 8 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.5 beats per minute (bpm)
Standard Deviation 18.08
|
-2.9 beats per minute (bpm)
Standard Deviation 15.07
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 9 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
90.7 beats per minute (bpm)
Standard Deviation 16.51
|
82.8 beats per minute (bpm)
Standard Deviation 15.66
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 9 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.8 beats per minute (bpm)
Standard Deviation 15.74
|
-1.1 beats per minute (bpm)
Standard Deviation 14.94
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 10 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
88.7 beats per minute (bpm)
Standard Deviation 15.73
|
85.1 beats per minute (bpm)
Standard Deviation 17.87
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 10 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.1 beats per minute (bpm)
Standard Deviation 17.47
|
1.6 beats per minute (bpm)
Standard Deviation 18.66
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 11 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
89.3 beats per minute (bpm)
Standard Deviation 16.55
|
82.0 beats per minute (bpm)
Standard Deviation 16.84
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 11 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.4 beats per minute (bpm)
Standard Deviation 16.75
|
-0.1 beats per minute (bpm)
Standard Deviation 17.81
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 12 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
90.8 beats per minute (bpm)
Standard Deviation 16.25
|
80.0 beats per minute (bpm)
Standard Deviation 13.91
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
0Day 12 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.2 beats per minute (bpm)
Standard Deviation 17.91
|
-1.4 beats per minute (bpm)
Standard Deviation 16.75
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 13 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
86.6 beats per minute (bpm)
Standard Deviation 13.51
|
81.4 beats per minute (bpm)
Standard Deviation 13.21
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 13 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.2 beats per minute (bpm)
Standard Deviation 17.17
|
1.1 beats per minute (bpm)
Standard Deviation 15.14
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 14 Observed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
87.0 beats per minute (bpm)
Standard Deviation 17.66
|
—
|
|
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Day 14 Change
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.2 beats per minute (bpm)
Standard Deviation 19.63
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Suicidality: The number and percentage of subjects reporting any suicidal ideation OR behavior throughout the assessment period, including baseline.
The C-SSRS measures both suicidal ideation and suicidal behavior and will be completed to assess lifetime suicidality before first dose of study drug, 3.5 hours after first daily dose of study drug on in-clinic treatment days, and then once a day before dosing during outpatient treatment days. C-SSRS will also be assessed at end of study/discontinuation.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Suicidality
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Suicidal ideation
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Suicidal behavior
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Emergence of suicidal ideation
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Emergence of serious suicidal ideation
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Worsening of suicidal ideation
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Emergence of suicidal behavior
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: The number of participants analyzed for each parameter differs from the overall number of participants analyzed as a result of missing data for some participants.
Hematology Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Laboratory Test Change From Baseline: Hematology
Hemoglobin (g/dL) : Below (Baseline)
|
25 Participants
|
27 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Hemoglobin (g/dL) : Normal (Baseline)
|
8 Participants
|
124 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Hemoglobin (g/dL) : Above (Baseline)
|
0 Participants
|
1 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Hematocrit (%) : Below (Baseline)
|
11 Participants
|
23 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Hematocrit (%) : Normal (Baseline)
|
6 Participants
|
120 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Hematocrit (%) : Above (Baseline)
|
0 Participants
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Platelet count (x10^9/L) : Below (Baseline)
|
11 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Platelet count (x10^9/L) : Normal (Baseline)
|
4 Participants
|
166 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Platelet count (x10^9/L) : Above (Baseline)
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Erythrocytes (x10^12/L) : Below (Baseline)
|
14 Participants
|
20 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Erythrocytes (x10^12/L) : Normal (Baseline)
|
11 Participants
|
122 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Erythrocytes (x10^12/L) : Above (Baseline)
|
0 Participants
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Erythrocytes distribution width (%) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Erythrocytes distribution width (%) : Normal (Baseline)
|
0 Participants
|
150 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Erythrocytes distribution width (%) : Above (Baseline)
|
0 Participants
|
8 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Mean corpuscular volume (fL) : Below (Baseline)
|
4 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Mean corpuscular volume (fL) : Normal (Baseline)
|
0 Participants
|
173 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Mean corpuscular volume (fL) : Above (Baseline)
|
0 Participants
|
4 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Leukocytes (x10^9/L) : Below (Baseline)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Leukocytes (x10^9/L) : Normal (Baseline)
|
2 Participants
|
167 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Leukocytes (x10^9/L) : Above (Baseline)
|
0 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Neutrophils/Leukocytes (%) : Below (Baseline)
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Neutrophils/Leukocytes (%) : Normal (Baseline)
|
2 Participants
|
163 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Neutrophils/Leukocytes (%) : Above (Baseline)
|
0 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Neutrophils (x10^9/L) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Neutrophils (x10^9/L) : Normal (Baseline)
|
1 Participants
|
182 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Neutrophils (x10^9/L) : Above (Baseline)
|
0 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Lymphocytes/Leukocytes (%) : Below (Baseline)
|
23 Participants
|
15 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Lymphocytes/Leukocytes (%) : Normal (Baseline)
|
32 Participants
|
103 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Lymphocytes/Leukocytes (%) : Above (Baseline)
|
1 Participants
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Lymphocytes, absolute (x10^9/L) : Below (Baseline)
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Lymphocytes, absolute (x10^9/L) : Normal (Baseline)
|
3 Participants
|
192 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Lymphocytes, absolute (x10^9/L) : Above (Baseline)
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Monocytes/Leukocytes (%) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Monocytes/Leukocytes (%) : Normal (Baseline)
|
1 Participants
|
159 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Monocytes/Leukocytes (%) : Above (Baseline)
|
0 Participants
|
17 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Monocytes (x10^9/L) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Monocytes (x10^9/L) : Normal (Baseline)
|
0 Participants
|
192 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Monocytes (x10^9/L) : Above (Baseline)
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Eosinophils absolute (x10^9/L) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Eosinophils absolute (x10^9/L) : Normal (Baseline)
|
0 Participants
|
176 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Eosinophils absolute (x10^9/L) : Above (Baseline)
|
0 Participants
|
10 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Eosinophils/Leukocytes (%) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Eosinophils/Leukocytes (%) : Normal (Baseline)
|
0 Participants
|
140 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Eosinophils/Leukocytes (%) : Above (Baseline)
|
0 Participants
|
31 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Prothrombin time (seconds) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Prothrombin time (seconds) : Normal (Baseline)
|
0 Participants
|
154 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Prothrombin time (seconds) : Above (Baseline)
|
0 Participants
|
17 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Activated Partial Thromboplastin Time (seconds) : Below (Baseline)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Activated Partial Thromboplastin Time (seconds) : Normal (Baseline)
|
0 Participants
|
154 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Hematology
Activated Partial Thromboplastin Time (seconds) : Above (Baseline)
|
0 Participants
|
19 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Participants Analyzed does not match the Participant Flow as a result of missing data for some participants.
Chemistry Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Protein (g/dL) : Above (Baseline)
|
0 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Alanine aminotransferase (U/L) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Alanine aminotransferase (U/L) : Normal (Baseline)
|
0 Participants
|
153 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Alanine aminotransferase (U/L) : Above (Baseline)
|
0 Participants
|
12 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Aspartate Aminotransferase (U/L) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Aspartate Aminotransferase (U/L) : Normal (Baseline)
|
0 Participants
|
164 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Aspartate Aminotransferase (U/L) : Above (Baseline)
|
0 Participants
|
16 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Gamma-glutamyl transferase (U/L) : Below (Baseline)
|
9 Participants
|
13 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Gamma-glutamyl transferase (U/L) : Normal (Baseline)
|
2 Participants
|
139 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Gamma-glutamyl transferase (U/L) : Above (Baseline)
|
0 Participants
|
6 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Alkaline phosphatase (U/L) : Below (Baseline)
|
6 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Alkaline phosphatase (U/L) : Normal (Baseline)
|
9 Participants
|
170 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Alkaline phosphatase (U/L) : Above (Baseline)
|
0 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Lactate dehydrogenase (U/L) : Below (Baseline)
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Lactate dehydrogenase (U/L) : Normal (Baseline)
|
3 Participants
|
164 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Lactate dehydrogenase (U/L) : Above (Baseline)
|
0 Participants
|
19 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Blood urea nitrogen (mg/dL) : Below (Baseline)
|
9 Participants
|
28 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Blood urea nitrogen (mg/dL) : Normal (Baseline)
|
28 Participants
|
127 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Blood urea nitrogen (mg/dL) : Above (Baseline)
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Creatinine (mg/dL) : Below (Baseline)
|
29 Participants
|
17 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Creatinine (mg/dL) : Normal (Baseline)
|
8 Participants
|
147 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Creatinine (mg/dL) : Above (Baseline)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Cholesterol (mg/dL) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Cholesterol (mg/dL) : Normal (Baseline)
|
0 Participants
|
153 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Cholesterol (mg/dL) : Above (Baseline)
|
0 Participants
|
13 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Triglycerides (mg/dL) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Triglycerides (mg/dL) : Normal (Baseline)
|
0 Participants
|
107 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Triglycerides (mg/dL) : Above (Baseline)
|
0 Participants
|
18 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Calcium (mg/dL) : Below (Baseline)
|
1 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Calcium (mg/dL) : Normal (Baseline)
|
7 Participants
|
182 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Calcium (mg/dL) : Above (Baseline)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Sodium (mEq/L) : Below (Baseline)
|
3 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Sodium (mEq/L) : Normal (Baseline)
|
3 Participants
|
187 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Sodium (mEq/L) : Above (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Potassium (mEq/L) : Below (Baseline)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Potassium (mEq/L) : Normal (Baseline)
|
2 Participants
|
183 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Potassium (mEq/L) : Above (Baseline)
|
0 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Chloride (mEq/L) : Below (Baseline)
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Chloride (mEq/L) : Normal (Baseline)
|
3 Participants
|
190 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Chloride (mEq/L) : Above (Baseline)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Carbon dioxide (bicarbonate) (mEq/L) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Carbon dioxide (bicarbonate) (mEq/L) : Normal (Baseline)
|
3 Participants
|
134 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Carbon dioxide (bicarbonate) (mEq/L) : Above (Baseline)
|
0 Participants
|
52 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Glucose (mg/dL) : Below (Baseline)
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Glucose (mg/dL) : Normal (Baseline)
|
1 Participants
|
130 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Glucose (mg/dL) : Above (Baseline)
|
0 Participants
|
19 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Phosphate (mg/dL) : Below (Baseline)
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Phosphate (mg/dL) : Normal (Baseline)
|
6 Participants
|
138 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Phosphate (mg/dL) : Above (Baseline)
|
1 Participants
|
26 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Protein (g/dL) : Below (Baseline)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Protein (g/dL) : Normal (Baseline)
|
0 Participants
|
190 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Below (Baseline)
|
11 Participants
|
18 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Normal (Baseline)
|
16 Participants
|
149 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Chemistry
Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Above (Baseline)
|
0 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Participants Analyzed does not match the Participant Flow as a result of missing data for some participants.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
n=286 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Specific Gravity : Below (Baseline)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Erythrocytes (/HPF) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Erythrocytes (/HPF) : Normal (Baseline)
|
0 Participants
|
136 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Erythrocytes (/HPF) : Above (Baseline)
|
0 Participants
|
28 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Leukocytes (/HPF) : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Leukocytes (/HPF) : Normal (Baseline)
|
0 Participants
|
175 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Leukocytes (/HPF) : Above (Baseline)
|
0 Participants
|
13 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Specific Gravity : Normal (Baseline)
|
0 Participants
|
188 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
Specific Gravity : Above (Baseline)
|
0 Participants
|
13 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
pH : Below (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
pH : Normal (Baseline)
|
0 Participants
|
204 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Laboratory Test Change From Baseline: Urinalysis
pH : Above (Baseline)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Population: Participants Analyzed does not match the Participant Flow as a result of missing data for some participants.
For each 12-lead ECG obtained during the study, the investigator made an overall interpretation of the ECG (normal, abnormal NCS, and abnormal CS). Shifts from normal at baseline to abnormal NCS and abnormal CS at the end of study predose and postdose assessments were summarized.
Outcome measures
| Measure |
OL: Lofexidine HCl
n=180 Participants
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 8AM
n=103 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 1PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 1PM
n=283 Participants
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: 3.5 hr Post 6PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Inpatient: Pre 11PM
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: Predose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
Outpatient: 3.5 hr Postdose
Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
|
|---|---|---|---|---|---|---|---|---|---|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
End of Study Post Dose · Abnormal (CS)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
Day 1 Post 8am Dose · Normal
|
139 Participants
|
16 Participants
|
0 Participants
|
155 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
Day 1 Post 8am Dose · Abnormal (NCS)
|
41 Participants
|
87 Participants
|
0 Participants
|
128 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
Day 1 Post 8am Dose · Abnormal (CS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
End of Study Pre Dose · Normal
|
83 Participants
|
20 Participants
|
0 Participants
|
103 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
End of Study Pre Dose · Abnormal (NCS)
|
19 Participants
|
38 Participants
|
0 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
End of Study Pre Dose · Abnormal (CS)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
End of Study Post Dose · Normal
|
77 Participants
|
26 Participants
|
0 Participants
|
103 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
End of Study Post Dose · Abnormal (NCS)
|
41 Participants
|
47 Participants
|
0 Participants
|
88 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
OL: Lofexidine HCl
Serious events: 2 serious events
Other events: 270 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OL: Lofexidine HCl
n=286 participants at risk
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested.
|
|---|---|
|
Psychiatric disorders
Delusion
|
0.35%
1/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.35%
1/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
|
Other adverse events
| Measure |
OL: Lofexidine HCl
n=286 participants at risk
Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested.
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Psychiatric disorders
Insomnia
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50.3%
144/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Psychiatric disorders
Anxiety
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37.4%
107/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Vascular disorders
Orthostatic hypotension
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33.6%
96/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Vascular disorders
Hypotension
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29.4%
84/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Cardiac disorders
Bradycardia
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25.2%
72/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Gastrointestinal disorders
Diarrhea
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18.9%
54/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Nervous system disorders
Sedation
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16.1%
46/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Nervous system disorders
Headache
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15.0%
43/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Gastrointestinal disorders
Abdominal pain upper
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14.7%
42/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Musculoskeletal and connective tissue disorders
Myalgia
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14.3%
41/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Gastrointestinal disorders
Constipation
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5.2%
15/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Gastrointestinal disorders
Dry Mouth
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8.4%
24/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Gastrointestinal disorders
Vomiting
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9.1%
26/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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General disorders
Pain
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8.4%
24/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Nervous system disorders
Somnolence
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7.3%
21/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Psychiatric disorders
Restlessness
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7.7%
22/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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General disorders
Fatigue
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6.6%
19/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Musculoskeletal and connective tissue disorders
Back pain
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5.2%
15/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Gastrointestinal disorders
Nausea
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17.5%
50/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Nervous system disorders
Dizziness
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16.4%
47/286 • AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place