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


Lead Sponsor: BioDelivery Sciences International

Source BioDelivery Sciences International
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.

Overall Status Completed
Start Date September 2012
Completion Date June 2014
Primary Completion Date June 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline to Week 12 in Average Daily Pain Intensity Scores Baseline, week 12
Secondary Outcome
Measure Time Frame
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
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire Baseline, week 12
Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale Baseline, Week 12
Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep Week 12
Enrollment 815

Intervention Type: Drug

Intervention Name: Buprenorphine

Description: Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily

Arm Group Label: Buprenorphine HCl Buccal Film

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching Placebo Buccal Film twice daily

Arm Group Label: Placebo Buccal Film



Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Andrew Finn, PharmD Study Director BioDelivery Sciences International, Inc.
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 | Ft. 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
Location Countries

United States

Verification Date

January 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo Buccal Film

Type: Placebo Comparator

Description: Twice Daily Dosing

Label: Buprenorphine HCl Buccal Film

Type: Experimental

Description: Twice Daily Dosing

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov