Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

NCT ID: NCT01256450

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-07-31

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.

Conditions

Pain; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BEMA Buprenorphine

buprenorphine buccal soluble film

Group Type: EXPERIMENTAL

Buprenorphine

Intervention Type: DRUG

buccal soluble film; applied to the buccal mucosa twice daily

BEMA Placebo

placebo buccal soluble film

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

buccal soluble film; applied to the buccal mucosa twice daily

Interventions

Buprenorphine

buccal soluble film; applied to the buccal mucosa twice daily

Intervention Type: DRUG

Placebo

buccal soluble film; applied to the buccal mucosa twice daily

Intervention Type: DRUG

Other Intervention Names

buprenorphine buccal soluble film; BEMA Buprenorphine; BELBUCA; buprenorphine HCl buccal film; Placebo buccal soluble film; Placebo buccal film; BEMA placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioDelivery Sciences International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Finn, PharmD

Role: STUDY_DIRECTOR

BioDelivery Sciences International, Inc.

Locations

Alabama Orthopaedic Center - Research

Birmingham, Alabama, United States

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Neuro-Pain Medical Center

Fresno, California, United States

University of California, San Diego Medical Center, UCSD Center for Pain Medicine

La Jolla, California, United States

Collaborative Neuroscience Network, Inc.

Long Beach, California, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Gold Coast Research, LLC

Plantation, Florida, United States

Accord Clinical Research, LLC

Port Orange, Florida, United States

Taylor Research, LLC

Marietta, Georgia, United States

Millennium Pain Center

Bloomington, Illinois, United States

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

International Clinical Research Institute

Leawood, Kansas, United States

MedVadis Research Corporation

Watertown, Massachusetts, United States

Office of Stephen H. Miller, MD

Las Vegas, Nevada, United States

Research Across American

New York, New York, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, United States

Allegheny Pain Management

Altoona, Pennsylvania, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Southwest Urgent Care Center

El Paso, Texas, United States

Lifetree Clinical Research

Salt Lake City, Utah, United States

Advanced Clinical Research

West Jordan, Utah, United States

Countries

United States

Other Identifiers

BUP-301

Identifier Type: -

Identifier Source: org_study_id