Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
Public ClinicalTrials.gov record NCT01633944. 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
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01633944
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 752 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
- Aug 2012 (Type not available)
- Primary completion
- Dec 2013 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Feb 27, 2017
2012 – 2013
United States locations
- U.S. sites
- 60
- U.S. states
- 24
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Horizon Research Group, Inc./Alabama Orthopedic Clinic | Mobile | Alabama | 36608 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Global Research | Anaheim | California | 92804 | — |
| Catalina Research Institute, LLC | Chino | California | 91710 | — |
| Synergy Clinical Research Center of Escondido | Escondido | California | 92025 | — |
| Adam D. Karns MD | Los Angeles | California | 90036 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Clinical Research of West Florida - Clearwater | Clearwater | Florida | 33765 | — |
| Century Clinical Research, Inc. | Daytona Beach | Florida | 32117 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Florida Health Center | Fort Lauderdale | Florida | 33312 | — |
| Eastern Research, Inc. | Hialeah | Florida | 33013 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Drug Study Institute | Jupiter | Florida | 33458 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| NEMA Research, Inc. | Naples | Florida | 34108 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Peninsula Research | Ormond Beach | Florida | 32174 | — |
| Gold Coast Research, L.L.C. | Plantation | Florida | 33317 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Clinical Research of West Florida - Tampa | Tampa | Florida | 33603 | — |
| National Pain Research Institute, LLC | Winter Park | Florida | 32789 | — |
| Atlanta Research Center | Atlanta | Georgia | 30319 | — |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | — |
| Drug Studies America | Marietta | Georgia | 30060 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Taylor Research, LLC | Marietta | Georgia | 30060 | — |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | — |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | — |
| International Clinical Research Institute, Inc. | Overland Park | Kansas | 66210 | — |
| Willis-Kinghton Physician Network/River Interventional Pain Specialist | Bossier City | Louisiana | 71111 | — |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | — |
| Best Clinical Trials, Inc. | New Orleans | Louisiana | 70115 | — |
| River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | — |
| MedVadis Research Corp. | Watertown | Massachusetts | 02472 | — |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | — |
| The Center for Clinical Trials | Biloxi | Mississippi | 39531 | — |
| Office of Robert Kaplan, DO | Las Vegas | Nevada | 89119 | — |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | — |
| Upstate Clinical Research Associates LLC | Williamsville | New York | 14221 | — |
| PharmQuest, LLC | Greensboro | North Carolina | 27408 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Plains Medical Clinic, LLC | Fargo | North Dakota | 58104 | — |
| Clinical Inquest Center, Ltd. | Beavercreek | Ohio | 45432 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Optimed Research, Ltd. | Columbus | Ohio | 43235 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | — |
| NPC Research | Oklahoma City | Oklahoma | 73109 | — |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19335 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| FutureSearch Clinical Trials - Austin | Austin | Texas | 78731 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | — |
| Advanced Clinical Research of Houston | Houston | Texas | 77062 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Innovative Clinical Trials | San Antonio | Texas | 78229 | — |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | — |
| Clinical Investigations Specialists, Inc. | Kenosha | Wisconsin | 53142 | — |
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 NCT01633944, 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 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01633944 live on ClinicalTrials.gov.