Clinical trial NCT01633944: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: CLBP
Chronic Low Back Pain
Chronic Pain
Back Pain
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Number of Participants With Response to Treatment (Responder) Using NRS Scale
timeFrame: Prior to open-label titration to Week 12 in double-blind treatment
measure: Number of Subjects With Rescue Medication Use
timeFrame: Week 1 to Week 12 in double-blind treatment
measure: Time to Optimal Dose of Open-label Study Medication
timeFrame: Up to 8 weeks in open-label titration
measure: Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
timeFrame: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
measure: Patient Global Impression of Change
timeFrame: Week 12
measure: Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group, Inc./Alabama Orthopedic Clinic
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Global Research
state: California
city: Chino
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center of Escondido
state: California
city: Los Angeles
country: United States
facility: Adam D. Karns MD
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida - Clearwater
state: Florida
city: Daytona Beach
country: United States
facility: Century Clinical Research, Inc.
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Ft. Lauderdale
country: United States
facility: Florida Health Center
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Naples
country: United States
facility: NEMA Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, L.L.C.
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida - Tampa
state: Florida
city: Winter Park
country: United States
facility: National Pain Research Institute, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Research Center
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Marietta
country: United States
facility: Taylor Research, LLC
state: Georgia
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Overland Park
country: United States
facility: International Clinical Research Institute, Inc.
state: Kansas
city: Bossier City
country: United States
facility: Willis-Kinghton Physician Network/River Interventional Pain Specialist
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Best Clinical Trials, Inc.
state: Louisiana
city: Shreveport
country: United States
facility: River Cities Clinical Research Center
state: Louisiana
city: Watertown
country: United States
facility: MedVadis Research Corp.
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Biloxi
country: United States
facility: The Center for Clinical Trials
state: Mississippi
city: Las Vegas
country: United States
facility: Office of Robert Kaplan, DO
state: Nevada
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates LLC
state: New York
city: Greensboro
country: United States
facility: PharmQuest, LLC
state: North Carolina
city: Winston Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Fargo
country: United States
facility: Plains Medical Clinic, LLC
state: North Dakota
city: Beavercreek
country: United States
facility: Clinical Inquest Center, Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, Ltd.
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: NPC Research
state: Oklahoma
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Austin
country: United States
facility: FutureSearch Clinical Trials - Austin
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Advanced Clinical Research of Houston
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Kenosha
country: United States
facility: Clinical Investigations Specialists, Inc.
state: Wisconsin
Study officials:
affiliation: Endo Pharmaceuticals
name: M. Todd Kirby, PhD
role: STUDY_DIRECTOR
References: