Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
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
1 other identifier
interventional
815
1 country
66
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 low-back-pain
Started Sep 2012
Typical duration for phase_3 low-back-pain
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
February 3, 2016
CompletedFebruary 27, 2017
January 1, 2017
1.7 years
August 27, 2012
November 4, 2015
January 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
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).
Baseline, week 12
Secondary Outcomes (8)
Number of Participants With Response to Treatment (Responder) Using NRS Scale
Prior to open-label titration to week 12 in double-blind treatment
Number of Subjects With Opioid Rescue Medication Use
Week 1 to Week 12
Time to Optimal Dose of Open-label Study Medication
Up to 8 weeks in open-label titration
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Patient Global Impression of Change
Week 12
- +3 more secondary outcomes
Study Arms (2)
Placebo Buccal Film
PLACEBO COMPARATORTwice Daily Dosing
Buprenorphine HCl Buccal Film
EXPERIMENTALTwice Daily Dosing
Interventions
Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily
Matching Placebo Buccal Film twice daily
Eligibility Criteria
You may qualify if:
- Diagnosis of moderate to severe low back pain for ≥6 months
- Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
- Stable health, as determine by Principal Investigator
- Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year
- Willing and able to comply with all protocol required visits and assessments
You may not qualify if:
- Current cancer related pain or received chemotherapy within 6 months of screening
- Subjects with history of other chronic painful conditions
- Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- Allergy or contraindications of any opioid or acetaminophen
- Surgical procedure for relief of pain within 6 months
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome or a family member with this condition
- Moderate to severe hepatic impairment
- Moderate to severe renal impairment
- Current or past history of alcohol abuse
- Positive urine toxicology screen for drug of abuse
- History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Haleyville Clinical Research LLC
Haleyville, Alabama, 35565, United States
Horizon Research Group. Inc / Alabama Orthopedice
Mobile, Alabama, 36608, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Global Research
Anaheim, California, 92804, United States
Catalina Research Institute, LLC
Chino, California, 91710, United States
Synergy Clinical Research Center of Escondido
Escondido, California, 92025, United States
RX Clinical Research, Inc.
Garden Grove, California, 92843, United States
Adam D. Karns, MD
Los Angeles, California, 90036, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Century Clinic Research
Daytona Beach, Florida, 32117, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Florida Health Center
Fort Lauderdale, Florida, 33312, United States
Eastern Research, Inc.
Hialeah, Florida, 33013, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Try Research, Inc.
Maitland, Florida, 32751, United States
NEMA Research, Inc.
Naples, Florida, 34108, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
National Pain Research Institute, LLC
Winter Park, Florida, 32789, United States
Atlanta Research Center
Atlanta, Georgia, 30319, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Taylor Research, LLC
Marietta, Georgia, 30060, United States
Georgia Pain & Spine Care & Better Health Clinical Research
Newnan, Georgia, 30265, United States
Clinical Investigations Specialists, Inc.
Gurnee, Illinois, 60031, United States
MediSphere Medical Research, LLC
Evansville, Indiana, 47714, United States
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, 50265, United States
International Clinical Research Institute, Inc.
Overland Park, Kansas, 66210, United States
Willis-Kinghton Physician Network / River Cities International Pain Specialist
Bossier City, Louisiana, 71111, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
River Cities Clinical Research Center
Shreveport, Louisiana, 71105, United States
MedVadis Research Corp.
Watertown, Massachusetts, 02472, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
The Center for Clinical Trials
Biloxi, Mississippi, 39531, United States
Office of Robert Kaplan, DO
Las Vegas, Nevada, 89119, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
PharmQuest, LLC
Greensboro, North Carolina, 27408, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, 58104, United States
Clinical Inquest Center, Ltd
Beavercreek, Ohio, 45432, United States
New Horizons Health Research
Cincinnati, Ohio, 45242, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Neuropsychiatric Research Center Research
Oklahoma City, Oklahoma, 73109, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
FutureSearch Clinical Trials
Austin, Texas, 78731, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Future Search Trials of Dallas, LP
Dallas, Texas, 75231, United States
Advanced Clinical Research of Houston
Houston, Texas, 77062, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Coordinator
- Organization
- Endo Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Andrew Finn, PharmD
BioDelivery Sciences International, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2012
First Posted
August 29, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
February 27, 2017
Results First Posted
February 3, 2016
Record last verified: 2017-01