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

BioDelivery Sciences International

Status and phase

Completed

Phase 3

Conditions

Pain

Low Back Pain

Treatments

Drug: Placebo

Drug: Buprenorphine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01256450

BUP-301

Details and patient eligibility

About

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).

Full 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.

Enrollment

334 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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