Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Public ClinicalTrials.gov record NCT01256450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01256450
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 334 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2010 (Type not available)
- Primary completion
- Jul 2011 (Actual)
- Completion
- Jul 2011 (Actual)
- Last update posted
- Feb 27, 2017
2010 – 2011
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Orthopaedic Center - Research | Birmingham | Alabama | 35209 | — |
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Neuro-Pain Medical Center | Fresno | California | 93710 | — |
| University of California, San Diego Medical Center, UCSD Center for Pain Medicine | La Jolla | California | 92037 | — |
| Collaborative Neuroscience Network, Inc. | Long Beach | California | 90806 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Gold Coast Research, LLC | Plantation | Florida | 33317 | — |
| Accord Clinical Research, LLC | Port Orange | Florida | 32129 | — |
| Taylor Research, LLC | Marietta | Georgia | 30060 | — |
| Millennium Pain Center | Bloomington | Illinois | 61701 | — |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | — |
| International Clinical Research Institute | Leawood | Kansas | 66211 | — |
| MedVadis Research Corporation | Watertown | Massachusetts | 02472 | — |
| Office of Stephen H. Miller, MD | Las Vegas | Nevada | 89144 | — |
| Research Across American | New York | New York | 10022 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | — |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | — |
| Allegheny Pain Management | Altoona | Pennsylvania | 16602 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| Southwest Urgent Care Center | El Paso | Texas | 79902 | — |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01256450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2017 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01256450 live on ClinicalTrials.gov.