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NCT02651584 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
A Phase 3 study, sponsored by Braeburn Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 428
- Enrollment target
NCT02651584: Completed Phase 3 study, sponsored by Braeburn Pharmaceuticals.
NCT02651584 is a Phase 3 study that has completed, run by Braeburn Pharmaceuticals. The registered enrollment target is 428 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02651584, a Phase 3 study, has completed, sponsored by Braeburn Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 428 participants
- Enrollment target
Study Summary
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
Primary Outcome
Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.
Interventions
- DRUG CAM2038 SC injection
- DRUG SL BPN/NX tabs
- DRUG placebo SC injections
- DRUG SL placebo tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT02651584 record still lists
NCT02651584 is an interventional study that assigns participants to a tested intervention. The registered 428 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which CAM2038 SC injection is the first listed.
NCT02651584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02651584 about?
NCT02651584 is a clinical study titled "Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence". Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
What is the current status of trial NCT02651584?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 428 participants. The study started on 2015-12. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02651584?
The interventions under investigation include: CAM2038 SC injection (DRUG), SL BPN/NX tabs (DRUG), placebo SC injections (DRUG), SL placebo tablets (DRUG).
Who is sponsoring clinical trial NCT02651584?
This trial is sponsored by Braeburn Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02651584's enrollment target sits among peer trials
428 878th of 2000 higher than 1,121 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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