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Completed Phase 3 Interventional Results available

Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects

ClinicalTrials.gov ID: NCT01675167

Public ClinicalTrials.gov record NCT01675167. 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.

ClinicalTrials.gov public records Last synced May 3, 2026, 1:55 AM EDT

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-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

Study identification

NCT ID
NCT01675167
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
BioDelivery Sciences International
Industry
Enrollment
815 participants

Conditions and interventions

Conditions

Interventions

  • Buprenorphine Drug
  • Placebo Drug

Drug

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 31, 2012
Primary completion
May 31, 2014
Completion
May 31, 2014
Last update posted
Feb 26, 2017

2012 – 2014

United States locations

U.S. sites
66
U.S. states
25
U.S. cities
60
Facility City State ZIP Site status
Parkway Medical Center Birmingham Alabama 35215
Haleyville Clinical Research LLC Haleyville Alabama 35565
Horizon Research Group. Inc / Alabama Orthopedice 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
RX Clinical Research, Inc. Garden Grove California 92843
Adam D. Karns, MD Los Angeles California 90036
Stamford Therapeutics Consortium Stamford Connecticut 06905
Century Clinic Research 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
FPA Clinical Research Kissimmee Florida 34741
Try Research, Inc. Maitland Florida 32751
NEMA Research, Inc. Naples Florida 34108
Compass Research, LLC Orlando Florida 32806
Peninsula Research, Inc. Ormond Beach Florida 32174
Gold Coast Research, LLC Plantation Florida 33317
Progressive Medical Research Port Orange Florida 32127
Clinical Research of West Florida, Inc. Tampa Florida 33603
Palm Beach Research Center West Palm Beach Florida 33409
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
Georgia Pain & Spine Care & Better Health Clinical Research Newnan Georgia 30265
Clinical Investigations Specialists, Inc. Gurnee Illinois 60031
MediSphere Medical Research, 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 Cities International Pain Specialist Bossier City Louisiana 71111
Clinical Trials Management, LLC Metairie Louisiana 70006
Best Clinical Trials, LLC 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
Comprehensive Clinical Research Berlin New Jersey 08009
Long Island Gastrointestinal Research Group Great Neck New York 11023
Upstate Clinical Research Associates 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 Health Research Cincinnati Ohio 45242
Prestige Clinical Research Franklin Ohio 45005
Health Research Institute Oklahoma City Oklahoma 73109
Neuropsychiatric Research Center 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 Texas 78731
KRK Medical Research Dallas Texas 75230
Future Search 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

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 NCT01675167, 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 26, 2017 · Synced May 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01675167 live on ClinicalTrials.gov.

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