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

BioDelivery Sciences International334 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

334

Conditions

Pain Low Back Pain

Interventions

BuprenorphineDRUG

buccal soluble film; applied to the buccal mucosa twice daily

PlaceboDRUG

buccal soluble film; applied to the buccal mucosa twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

Alabama Orthopaedic Center - Research

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change in Pain Intensity From Baseline to Week 12

Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Pain Intensity Over Time Using NRS Scale

Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

Time frame: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84

Number of Participants With Response to Treatment as Assessed by an NRS Scale

Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

Time frame: Week 12

Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)

Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.

Time frame: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)

Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale

Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).

Data from ClinicalTrials.gov

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