Trials / Completed
CompletedNCT01633944
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 752 (actual)
- Sponsor
- BioDelivery Sciences International · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buprenorphine | Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily |
| DRUG | Placebo | Matching Placebo Buccal Film twice daily |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2012-07-06
- Last updated
- 2017-02-27
- Results posted
- 2016-02-03
Locations
60 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01633944. Inclusion in this directory is not an endorsement.