Trial Outcomes & Findings for Lofexidine for Adults Undergoing Lumbar Spine Surgery (NCT NCT04126083)

Results Overview

The number of patients who achieve a 50% reduction in daily opioid dose at day 12.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

12 days

Results posted on

2022-02-23

Participant milestones
Measure	Lofexidine Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily. Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Lofexidine Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily. Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily
Overall Study Withdrawal by Subject	1

Lofexidine for Adults Undergoing Lumbar Spine Surgery

Baseline characteristics by cohort
Measure	Lofexidine n=6 Participants Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily. Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily
Age, Continuous	53 years n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race/Ethnicity, Customized White	5 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=93 Participants
Region of Enrollment United States	6 participants n=93 Participants

Timeframe: 12 days

The number of patients who achieve a 50% reduction in daily opioid dose at day 12.

Outcome measures
Measure	Lofexidine n=6 Participants Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily. Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily
Opioid Tapering	5 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Lofexidine n=6 participants at risk Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily. Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily
Cardiac disorders Orthostatic Hypotension	16.7% 1/6 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 days.

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