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NCT01256450 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
A Phase 3 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 334
- Enrollment target
NCT01256450: Completed Phase 3 study, sponsored by BioDelivery Sciences International.
NCT01256450 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 334 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01256450, a Phase 3 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 334 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
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 | 334 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT01256450 record still lists
NCT01256450 is an interventional study that assigns participants to a tested intervention. The registered 334 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 (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01256450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01256450 about?
NCT01256450 is a clinical study titled "Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain". The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
What is the current status of trial NCT01256450?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 334 participants. The study started on 2010-11. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01256450?
The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01256450?
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 NCT01256450's enrollment target sits among peer trials
334 1061st of 2000 higher than 940 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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