Clinical trial NCT01256450: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Low Back Pain
Keywords: buccal soluble film
enriched enrollment
randomized withdrawal
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 334
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 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.

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

Primary outcomes:
measure: Change in Pain Intensity From Baseline to Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Pain Intensity Over Time Using NRS Scale
timeFrame: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
measure: Number of Participants With Response to Treatment as Assessed by an NRS Scale
timeFrame: Week 12
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: Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
timeFrame: Baseline, 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 Subject's Overall Satisfaction With Study Drug
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
timeFrame: Baseline, Week 12
measure: Use of Rescue Medication
timeFrame: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Orthopaedic Center - Research
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: La Jolla
country: United States
facility: University of California, San Diego Medical Center, UCSD Center for Pain Medicine
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Marietta
country: United States
facility: Taylor Research, LLC
state: Georgia
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Leawood
country: United States
facility: International Clinical Research Institute
state: Kansas
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Las Vegas
country: United States
facility: Office of Stephen H. Miller, MD
state: Nevada
city: New York
country: United States
facility: Research Across American
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: El Paso
country: United States
facility: Southwest Urgent Care Center
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: BioDelivery Sciences International, Inc.
name: Andrew Finn, PharmD
role: STUDY_DIRECTOR
References: