Last reviewed · How we verify
A Phase 3, Open-Label, Safety Study of Lofexidine (NU LEAF)
The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and buprenorphine. This study will take place in a variety of clinical scenarios, both in-clinic and outpatient settings.
Details
| Lead sponsor | USWM, LLC (dba US WorldMeds) |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 286 |
| Start date | 2015-02 |
| Completion | 2015-10 |
Conditions
- Opioid Withdrawal
Interventions
- Lofexidine
Primary outcomes
- Overall Occurrence of Treatment Emergent Adverse Events (TEAEs) — Days 1-14
Subjects with at least 1 TEAE occurring on days 1-14. - Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs) — Days 1-14
- Overall Treatment Emergent Adverse Events (TEAEs) by Severity — Days 1-14
- Occurrence of Per Protocol Adverse Events of Special Interest (AESI) — Day 1 to Day 14
- Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal — Day 1 to Day 14
- Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign — Day 1 to Day 14
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.
Countries
United States