Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
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
1 other identifier
interventional
334
1 country
24
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
Started Nov 2010
Shorter than P25 for phase_3 pain
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 7, 2010
CompletedFirst Posted
Study publicly available on registry
December 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
December 8, 2015
CompletedFebruary 27, 2017
January 1, 2017
8 months
December 7, 2010
November 4, 2015
January 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain Intensity From Baseline to Week 12
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 (9)
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
Number of Participants With Response to Treatment as Assessed by an NRS Scale
Week 12
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)
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Baseline, Week 12
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Baseline, Week 12
- +4 more secondary outcomes
Study Arms (2)
BEMA Buprenorphine
EXPERIMENTALbuprenorphine buccal soluble film
BEMA Placebo
PLACEBO COMPARATORplacebo buccal soluble film
Interventions
buccal soluble film; applied to the buccal mucosa twice daily
buccal soluble film; applied to the buccal mucosa twice daily
Eligibility Criteria
You may qualify if:
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 \[11 point numerical rating scale\] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs \[NSAIDs\], and muscle relaxants) of approximately 12 to 24 hours
- Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
- Female subjects of childbearing potential must be using a recognized effective method of birth control
- Written informed consent obtained at Screening, prior to any procedure being performed
You may not qualify if:
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
- Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- Corrected QT (QTc) interval of \>450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome, or an immediate family member with this condition
- Diagnosis of moderate to severe hepatic impairment.
- History of severe emesis with opioids
- Clinically significant sleep apnea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Alabama Orthopaedic Center - Research
Birmingham, Alabama, 35209, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
University of California, San Diego Medical Center, UCSD Center for Pain Medicine
La Jolla, California, 92037, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
Taylor Research, LLC
Marietta, Georgia, 30060, United States
Millennium Pain Center
Bloomington, Illinois, 61701, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
International Clinical Research Institute
Leawood, Kansas, 66211, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Office of Stephen H. Miller, MD
Las Vegas, Nevada, 89144, United States
Research Across American
New York, New York, 10022, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Allegheny Pain Management
Altoona, Pennsylvania, 16602, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Southwest Urgent Care Center
El Paso, Texas, 79902, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Advanced Clinical Research
West Jordan, Utah, 84088, 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2010
First Posted
December 8, 2010
Study Start
November 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
February 27, 2017
Results First Posted
December 8, 2015
Record last verified: 2017-01