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NCT02946073 · ClinicalTrials.gov registry record · Phase 3
Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
A Phase 3 study, sponsored by Braeburn Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,053
- Enrollment target
NCT02946073: Completed Phase 3 study, sponsored by Braeburn Pharmaceuticals.
NCT02946073 is a Phase 3 study that has completed, run by Braeburn Pharmaceuticals. The registered enrollment target is 1,053 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02946073, a Phase 3 study, has completed, sponsored by Braeburn Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,053 participants
- Enrollment target
Study Summary
This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that requires continuous, around-the-clock (ATC) opioid treatment ≥ 40 mg morphine equivalent dose (MED). The study includes 5 phases: A Screening Phase (up to 2 weeks), a Transition Phase (up to 2 weeks), an Open-Label Titration Phase (up to 10 weeks), a Double-Blind Treatment Phase including a Final Study Visit (12 weeks), and a Follow-up Phase (4 weeks). The overall duration of participation in the core phase of the study (randomized Double-Blind Phase) is up to 30 weeks, from the Screening Phase through the Follow-up Phase. Subjects who complete the Double-Blind Treatment Study Phase will be offered an opportunity to continue treatment in an open label safety extension for up to 60 weeks. Additional subjects may be recruited to open label safety extension to meet the goal of 100 subjects with 60 weeks of treatment.
Primary Outcome
Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain.
Interventions
- OTHER Placebo
- DRUG buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,053 participants |
| Start Date | 2016-09 |
| Est. Completion | 2019-02 |
| Phase | Phase 3 |
What the finished NCT02946073 record still lists
NCT02946073 is an interventional study that assigns participants to a tested intervention. Its 1,053 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02946073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02946073 about?
NCT02946073 is a clinical study titled "Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain". This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that requires continuous, around-the-clock (ATC) opioid treatment ≥ 40 mg morphine...
What is the current status of trial NCT02946073?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,053 participants. The study started on 2016-09. Estimated completion is 2019-02.
What interventions are being tested in trial NCT02946073?
The interventions under investigation include: Placebo (OTHER), buprenorphine (DRUG).
Who is sponsoring clinical trial NCT02946073?
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 NCT02946073's enrollment target sits among peer trials
1,053 278th of 2000 higher than 1,723 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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