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NCT01633944 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
A Phase 3 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 752
- Enrollment target
NCT01633944: Completed Phase 3 study, sponsored by BioDelivery Sciences International.
NCT01633944 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 752 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01633944, a Phase 3 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 752 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
Primary Outcome
Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Interventions
- DRUG Placebo
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01633944 record still lists
NCT01633944 is an interventional study that assigns participants to a tested intervention. The registered 752 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01633944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01633944 about?
NCT01633944 is a clinical study titled "Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects". The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
What is the current status of trial NCT01633944?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 752 participants. The study started on 2012-08. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01633944?
The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01633944?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01633944's enrollment target sits among peer trials
752 460th of 2000 higher than 1,539 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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