Back to resultsEfficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
Primary Purpose
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 Low Back Pain focused on measuring CLBP, Chronic Low Back Pain, Chronic Pain, Back Pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Horizon Research Group, Inc./Alabama Orthopedic Clinic
- Arizona Research Center
- Global Research
- Catalina Research Institute, LLC
- Synergy Clinical Research Center of Escondido
- Adam D. Karns MD
- Stamford Therapeutics Consortium
- Clinical Research of West Florida - Clearwater
- Century Clinical Research, Inc.
- Avail Clinical Research, LLC
- Florida Health Center
- Eastern Research, Inc.
- Florida Institute of Medical Research
- Drug Study Institute
- Health Awareness, Inc.
- NEMA Research, Inc.
- Compass Research, LLC
- Peninsula Research
- Gold Coast Research, L.L.C.
- Progressive Medical Research
- Clinical Research of West Florida - Tampa
- National Pain Research Institute, LLC
- Atlanta Research Center
- River Birch Research Alliance, LLC
- Drug Studies America
- Georgia Institute for Clinical Research, LLC
- Taylor Research, LLC
- MediSphere Medical Research Center, LLC
- Integrated Clinical Trial Services, Inc.
- International Clinical Research Institute, Inc.
- Willis-Kinghton Physician Network/River Interventional Pain Specialist
- Clinical Trials Management, LLC
- Best Clinical Trials, Inc.
- River Cities Clinical Research Center
- MedVadis Research Corp.
- Great Lakes Research Group, Inc.
- The Center for Clinical Trials
- Office of Robert Kaplan, DO
- Long Island Gastrointestinal Research Group
- Upstate Clinical Research Associates LLC
- PharmQuest, LLC
- The Center for Clinical Research
- Plains Medical Clinic, LLC
- Clinical Inquest Center, Ltd.
- New Horizons Clinical Research
- Optimed Research, Ltd.
- Prestige Clinical Research
- Health Research Institute
- NPC Research
- Brandywine Clinical Research
- Altoona Center for Clinical Research
- Health Concepts
- FutureSearch Clinical Trials - Austin
- KRK Medical Research
- FutureSearch Trials of Dallas, LP
- Advanced Clinical Research of Houston
- Clinical Trial Network
- Innovative Clinical Trials
- Highland Clinical Research
- Clinical Investigations Specialists, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Buprenorphine HCl Buccal Film
Arm Description
Twice Daily Dosing
Twice Daily Dosing
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of Participants With Response to Treatment (Responder) Using NRS Scale
Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).
Number of Subjects With Rescue Medication Use
Use of analgesic rescue medication recorded in subject diary.
Time to Optimal Dose of Open-label Study Medication
Overall time to reach the "optimal" dose of study medication required to progress to double-blind treatment.
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 discontinuation due to adverse events in the double-blind treatment phase.
Patient Global Impression of Change
Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)
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 Medical Outcomes Score Sleep Subscale
Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).
Full Information
NCT ID
NCT01633944
First Posted
July 2, 2012
Last Updated
January 12, 2017
Sponsor
BioDelivery Sciences International
1. Study Identification
Unique Protocol Identification Number
NCT01633944
Brief Title
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
CLBP, Chronic Low Back Pain, Chronic Pain, Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
752 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Twice Daily Dosing
Arm Title
Buprenorphine HCl Buccal Film
Arm Type
Experimental
Arm Description
Twice Daily Dosing
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
BELBUCA, Buprenorphine HCl Buccal Film, BEMA Buprenorphine, EN3409
Intervention Description
Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Buccal Film, BEMA Placebo
Intervention Description
Matching Placebo Buccal Film twice daily
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
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
Number of Participants With Response to Treatment (Responder) Using NRS Scale
Description
Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Prior to open-label titration to Week 12 in double-blind treatment
Title
Number of Subjects With Rescue Medication Use
Description
Use of analgesic rescue medication recorded in subject diary.
Time Frame
Week 1 to Week 12 in double-blind treatment
Title
Time to Optimal Dose of Open-label Study Medication
Description
Overall time to reach the "optimal" dose of study medication required to progress to double-blind treatment.
Time Frame
Up to 8 weeks in open-label titration
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 discontinuation due to adverse events in the double-blind treatment phase.
Time Frame
Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Title
Patient Global Impression of Change
Description
Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)
Time Frame
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 Medical Outcomes Score Sleep Subscale
Description
Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Todd Kirby, PhD
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Horizon Research Group, Inc./Alabama Orthopedic Clinic
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
Global Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Synergy Clinical Research Center of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Adam D. Karns MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Clinical Research of West Florida - Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Century Clinical Research, Inc.
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Avail Clinical Research, LLC
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Florida Health Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Eastern Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
NEMA Research, Inc.
City
Naples
State/Province
Florida
ZIP/Postal Code
34108
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Peninsula Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Gold Coast Research, L.L.C.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Clinical Research of West Florida - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
National Pain Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30319
Country
United States
Facility Name
River Birch Research Alliance, LLC
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Institute for Clinical Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Taylor Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Integrated Clinical Trial Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
International Clinical Research Institute, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Willis-Kinghton Physician Network/River Interventional Pain Specialist
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Best Clinical Trials, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
MedVadis Research Corp.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
The Center for Clinical Trials
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Office of Robert Kaplan, DO
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Upstate Clinical Research Associates LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
PharmQuest, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
The Center for Clinical Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Plains Medical Clinic, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Clinical Inquest Center, Ltd.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Optimed Research, Ltd.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
NPC Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
FutureSearch Clinical Trials - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
KRK Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Advanced Clinical Research of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Clinical Investigations Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
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