Back to resultsEfficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Primary Purpose
Pain, Low Back Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring buccal soluble film, enriched enrollment, randomized withdrawal
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Alabama Orthopaedic Center - Research
- Coastal Clinical Research, Inc.
- Arizona Research Center
- Neuro-Pain Medical Center
- University of California, San Diego Medical Center, UCSD Center for Pain Medicine
- Collaborative Neuroscience Network, Inc.
- Avail Clinical Research, LLC
- Health Awareness, Inc.
- Gold Coast Research, LLC
- Accord Clinical Research, LLC
- Taylor Research, LLC
- Millennium Pain Center
- MediSphere Medical Research Center, LLC
- International Clinical Research Institute
- MedVadis Research Corporation
- Office of Stephen H. Miller, MD
- Research Across American
- Wake Research Associates, LLC
- The Center for Clinical Research, LLC
- Allegheny Pain Management
- FutureSearch Trials of Neurology
- Southwest Urgent Care Center
- Lifetree Clinical Research
- Advanced Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BEMA Buprenorphine
BEMA Placebo
Arm Description
buprenorphine buccal soluble film
placebo buccal soluble film
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Change in pain intensity = average of daily pain scores from the last 7 days prior to each 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).
Number of Participants With Response to Treatment as Assessed by an NRS Scale
Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.
Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Use of Rescue Medication
Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.
Full Information
NCT ID
NCT01256450
First Posted
December 7, 2010
Last Updated
January 12, 2017
Sponsor
BioDelivery Sciences International
1. Study Identification
Unique Protocol Identification Number
NCT01256450
Brief Title
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioDelivery Sciences International
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.
Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Low Back Pain
Keywords
buccal soluble film, enriched enrollment, randomized withdrawal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BEMA Buprenorphine
Arm Type
Experimental
Arm Description
buprenorphine buccal soluble film
Arm Title
BEMA Placebo
Arm Type
Placebo Comparator
Arm Description
placebo buccal soluble film
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
buprenorphine buccal soluble film, BEMA Buprenorphine, BELBUCA, buprenorphine HCl buccal film
Intervention Description
buccal soluble film; applied to the buccal mucosa twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo buccal soluble film, Placebo buccal film, BEMA placebo
Intervention Description
buccal soluble film; applied to the buccal mucosa twice daily
Primary Outcome Measure Information:
Title
Change in Pain Intensity From Baseline to Week 12
Description
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).
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Description
Change in pain intensity = average of daily pain scores from the last 7 days prior to each 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).
Time Frame
Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
Title
Number of Participants With Response to Treatment as Assessed by an NRS Scale
Description
Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Week 12
Title
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Description
Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
Time Frame
Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Title
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Description
Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Description
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Description
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Description
Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Description
Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Time Frame
Baseline, Week 12
Title
Use of Rescue Medication
Description
Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.
Time Frame
Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Finn, PharmD
Organizational Affiliation
BioDelivery Sciences International, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Orthopaedic Center - Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
University of California, San Diego Medical Center, UCSD Center for Pain Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Gold Coast Research, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Taylor Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
International Clinical Research Institute
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Office of Stephen H. Miller, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Research Across American
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Allegheny Pain Management
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Southwest Urgent Care Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
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