Trial Outcomes & Findings for Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain (NCT NCT03254459)
NCT ID: NCT03254459
Last Updated: 2018-10-29
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Days 1 to 8
Results posted on
2018-10-29
Participant Flow
Participant milestones
| Measure |
Standard of Care Narcotic Therapy
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
40
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
23
|
Reasons for withdrawal
| Measure |
Standard of Care Narcotic Therapy
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
20
|
|
Overall Study
Withdrawal by Subject Consent
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Miscellaneous
|
0
|
1
|
Baseline Characteristics
Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain
Baseline characteristics by cohort
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 11.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 to 8Population: Safety population, all participants who received study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug.
Outcome measures
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
33 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Days 1 to7Population: Safety population, all participants who received study drug.
Zofran was used at the clinician's discretion as rescue medication for nausea.
Outcome measures
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Percentage of Participants Provided Rescue Medication for Nausea
|
12 percentage of participants
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 to 7Population: Safety population, all participants who received study drug.
Zofran was used at the clinician's discretion as rescue medication for nausea. Time "0" is defined as the time of the administration of study drug.
Outcome measures
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)
|
NA hours
Data could not be calculated as more than 50% of subjects discontinued prior to Day 8.
|
11.25 hours
Interval 5.6 to 23.13
|
SECONDARY outcome
Timeframe: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 daysPopulation: Safety population, all participants who received study drug.
Zofran was used at the clinician's discretion as rescue medication for nausea. The total use of rescue medication was calculated for the following 4 time-frames: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days.
Outcome measures
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days
0 to 24 hours
|
9 cumulative number of rescue doses
|
68 cumulative number of rescue doses
|
|
Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days
0 to 48 hours
|
18 cumulative number of rescue doses
|
92 cumulative number of rescue doses
|
|
Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days
0 to 72 hours
|
22 cumulative number of rescue doses
|
110 cumulative number of rescue doses
|
|
Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days
0 to 7 days
|
42 cumulative number of rescue doses
|
152 cumulative number of rescue doses
|
SECONDARY outcome
Timeframe: 90 Minutes,12, 24, 48 and 72 HoursPopulation: Safety population, all participants who received study drug.
Pulse oximetry is a non-invasive method to measure a person's oxygen saturation.
Outcome measures
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
90 minutes
|
96.3 percentage of oxygen saturation
Standard Deviation 1.99
|
96.0 percentage of oxygen saturation
Standard Deviation 2.11
|
|
Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
12 hours
|
96.0 percentage of oxygen saturation
Standard Deviation 1.93
|
95.8 percentage of oxygen saturation
Standard Deviation 2.06
|
|
Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
24 hours
|
96.9 percentage of oxygen saturation
Standard Deviation 1.63
|
96.6 percentage of oxygen saturation
Standard Deviation 2.27
|
|
Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
48 hours
|
96.5 percentage of oxygen saturation
Standard Deviation 2.01
|
96.0 percentage of oxygen saturation
Standard Deviation 2.15
|
|
Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
72 hours
|
97.3 percentage of oxygen saturation
Standard Deviation 1.36
|
96.2 percentage of oxygen saturation
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dosePopulation: Safety population, all participants who received study drug.
A standard 12-lead ECG will be performed after the participant is in the supine (lying face up) position for 5 minutes.
Outcome measures
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
Pre-dose
|
26 Participants
|
32 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
90 minutes
|
33 Participants
|
30 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
12 hours
|
31 Participants
|
34 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
24 hours
|
23 Participants
|
29 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
48 hours
|
18 Participants
|
25 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
72 hours
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose on Days 1 to 4 and End of Study Day 8Population: Safety population, all participants who received study drug.
Study staff will perform a sublingual (under the tongue) assessment, noting the color of mucosa and whether inflammation is present.
Outcome measures
| Measure |
Standard of Care Narcotic Therapy
n=50 Participants
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 Participants
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Number of Participants With Abnormal Oral Cavity Examinations
Pre-dose
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Oral Cavity Examinations
90 minutes
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Oral Cavity Examinations
12 hours
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Oral Cavity Examinations
24 hours
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Oral Cavity Examinations
48 hours
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Oral Cavity Examinations
72 hours
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care Narcotic Therapy
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Buprenorphine Sublingual Spray 0.5 mg
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care Narcotic Therapy
n=50 participants at risk
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 participants at risk
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
General disorders
Hematoma
|
0.00%
0/50 • Screening to Day 8
|
2.0%
1/50 • Screening to Day 8
|
Other adverse events
| Measure |
Standard of Care Narcotic Therapy
n=50 participants at risk
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Morphine: Morphine
Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet
|
Buprenorphine Sublingual Spray 0.5 mg
n=50 participants at risk
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.0%
17/50 • Screening to Day 8
|
78.0%
39/50 • Screening to Day 8
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • Screening to Day 8
|
52.0%
26/50 • Screening to Day 8
|
|
Gastrointestinal disorders
Constipation
|
8.0%
4/50 • Screening to Day 8
|
8.0%
4/50 • Screening to Day 8
|
|
Nervous system disorders
Dizziness
|
10.0%
5/50 • Screening to Day 8
|
22.0%
11/50 • Screening to Day 8
|
|
Nervous system disorders
Headache
|
16.0%
8/50 • Screening to Day 8
|
18.0%
9/50 • Screening to Day 8
|
|
Nervous system disorders
Somnolence
|
4.0%
2/50 • Screening to Day 8
|
6.0%
3/50 • Screening to Day 8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.0%
3/50 • Screening to Day 8
|
28.0%
14/50 • Screening to Day 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50 • Screening to Day 8
|
8.0%
4/50 • Screening to Day 8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
4/50 • Screening to Day 8
|
16.0%
8/50 • Screening to Day 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place