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NCT01675167 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
A Phase 3 study of Low Back Pain, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 815
- Enrollment target
- 20
- Study locations
NCT01675167: Completed Phase 3 study of Low Back Pain, sponsored by BioDelivery Sciences International.
NCT01675167 is a Phase 3 study of Low Back Pain that has completed, run by BioDelivery Sciences International. The registered enrollment target is 815 participants, above the 497-participant average among 122 other Low Back Pain trials with a reported enrollment target (64% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675167, a Phase 3 study of Low Back Pain, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 815 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced 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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Buprenorphine
Study Locations (20)
Florida
- Century Clinic Research - Daytona Beach
- Avail Clinical Research, LLC - DeLand
- Florida Health Center - Fort Lauderdale
- Eastern Research, Inc. - Hialeah
- Florida Institute of Medical Research - Jacksonville
- Drug Study Institute - Jupiter
- Health Awareness, Inc. - Jupiter
- FPA Clinical Research - Kissimmee
- Try Research, Inc. - Maitland
- NEMA Research, Inc. - Naples
California
- Global Research - Anaheim
- Catalina Research Institute, LLC - Chino
- Synergy Clinical Research Center of Escondido - Escondido
- RX Clinical Research, Inc. - Garden Grove
- Adam D. Karns, MD - Los Angeles
Alabama
- Parkway Medical Center - Birmingham
- Haleyville Clinical Research LLC - Haleyville
- Horizon Research Group. Inc / Alabama Orthopedice - Mobile
Arizona
- Arizona Research Center - Phoenix
Connecticut
- Stamford Therapeutics Consortium - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 815 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01675167 record still lists
NCT01675167 is an interventional study that assigns participants to a tested intervention. The registered 815 participants enrollment target is mid-sized for trials with a published cap, above the 497-participant average among 122 other Low Back Pain trials with a reported enrollment target (64% higher).
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01675167 names 20 study sites across 5 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01675167 about?
NCT01675167 is a clinical study titled "Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects". The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced 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 NCT01675167?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 815 participants. The study started on 2012-09. Estimated completion is 2014-06.
What conditions does trial NCT01675167 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT01675167?
The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01675167?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01675167 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01675167's enrollment target sits among peer trials
815 9th of 122 higher than 114 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain 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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