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NCT00941304 · ClinicalTrials.gov registry record · Phase 2
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
A Phase 2 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
NCT00941304: Completed Phase 2 study, sponsored by BioDelivery Sciences International.
NCT00941304 is a Phase 2 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 153 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00941304, a Phase 2 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
Primary Outcome
Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"
Interventions
- DRUG Oxycodone
- DRUG Buprenorphine
- DRUG Placebo Film
- DRUG Placebo Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2009-08 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00941304 record still lists
NCT00941304 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 4 interventions - of which Oxycodone is the first listed.
NCT00941304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00941304 about?
NCT00941304 is a clinical study titled "Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain". The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
What is the current status of trial NCT00941304?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2009-08. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00941304?
The interventions under investigation include: Oxycodone (DRUG), Buprenorphine (DRUG), Placebo Film (DRUG), Placebo Capsule (DRUG).
Who is sponsoring clinical trial NCT00941304?
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 NCT00941304's enrollment target sits among peer trials
153 449th of 2000 higher than 1,549 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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