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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 is a Phase 3 study that has completed, run by Braeburn Pharmaceuticals. The registered enrollment target is 1,053 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02946073
The ClinicalTrials.gov registry entry for NCT02946073 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,053 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Braeburn Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02946073 reports 0 study locations.
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.
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