drugset / Trial / NCT00941304
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
Timeline
- Start
- 2009-08
- Primary completion
- 2009-11
- Completion
- 2009-11
Outcome
Missed primary endpoint
registry 0.25-mg Buprenorphine HCl Buccal Film, M2 vs Placebo; p = .4739; LS Mean Difference 3.34 (95% CI -5.94 to 12.62); ANCOVA NCT00941304 ↗
registry 0.5-mg Buprenorphine HCl Buccal Film, M2 vs Placebo; p = .2183; LS Mean Difference 6.26 (95% CI -3.81 to 16.34); ANCOVA NCT00941304 ↗
registry 0.5-mg Buprenorphine HCl Buccal Film, M1 vs Placebo; p = .0809; LS Mean Difference 8.74 (95% CI -1.11 to 18.56); ANCOVA NCT00941304 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 0.25 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 0.5 mg | Other |
| Comparator | Oxycodone | Other / unclassified | 5 mg | Oral |