Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
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
1 other identifier
interventional
752
1 country
60
Brief Summary
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.
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 Aug 2012
60 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
July 2, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
February 3, 2016
CompletedFebruary 27, 2017
January 1, 2017
1.3 years
July 2, 2012
November 3, 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 (7)
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 Rescue Medication Use
Week 1 to Week 12 in double-blind treatment
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
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORTwice Daily Dosing
Buprenorphine HCl Buccal Film
EXPERIMENTALTwice Daily Dosing
Interventions
Buprenorphine HCl Buccal Film at doses ranging from 75-600 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 non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)
- Stable health, as determined by Principal Investigator
- Are female who are practicing abstinence or using a medically acceptable form of contraception or have been 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 with 6 months of screening
- Receiving opioid analgesic medication \>10 mg MSE per day within 28 days of screening
- Subjects with a 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 to any opioid or acetaminophen
- Surgical procedure for relief of pain with 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 (60)
Horizon Research Group, Inc./Alabama Orthopedic Clinic
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
Adam D. Karns MD
Los Angeles, California, 90036, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Clinical Research of West Florida - Clearwater
Clearwater, Florida, 33765, United States
Century Clinical Research, Inc.
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
NEMA Research, Inc.
Naples, Florida, 34108, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Peninsula Research
Ormond Beach, Florida, 32174, United States
Gold Coast Research, L.L.C.
Plantation, Florida, 33317, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Clinical Research of West Florida - Tampa
Tampa, Florida, 33603, 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
MediSphere Medical Research Center, 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 Interventional Pain Specialist
Bossier City, Louisiana, 71111, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Best Clinical Trials, Inc.
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
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Upstate Clinical Research Associates LLC
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 Clinical Research
Cincinnati, Ohio, 45242, United States
Optimed Research, Ltd.
Columbus, Ohio, 43235, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
NPC 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
Austin, Texas, 78731, United States
KRK Medical Research
Dallas, Texas, 75230, United States
FutureSearch 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
Clinical Investigations Specialists, Inc.
Kenosha, Wisconsin, 53142, 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
M. Todd Kirby, PhD
Endo Pharmaceuticals
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
July 2, 2012
First Posted
July 6, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 27, 2017
Results First Posted
February 3, 2016
Record last verified: 2017-01