Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain

Purdue Pharma LP539 enrolled

Overview

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

539

Conditions

Low Back Pain

Interventions

Buprenorphine transdermal systemDRUG

Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days

PlaceboDRUG

transdermal system (placebo) worn for 7 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening, * Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \<5 mg oxycodone (or equivalent) per day, * Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy Exclusion Criteria: * Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period, * Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids, * Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives. Other protocol-specific inclusion/exclusion criteria may apply.

Locations (86)

Outcomes

Primary Outcomes

Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.

Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.

Time frame: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.

Secondary Outcomes

The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase

Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.

Time frame: weeks 2-12

The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase

The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.

Time frame: Weeks 4, 8, 12 of double-blind phase

Data from ClinicalTrials.gov

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Research Facility

Anniston, Alabama, United States

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Radiant Research; Phoenix Southeast

Chandler, Arizona, United States

Arizona Research Center Inc.

Phoenix, Arizona, United States

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Anaheim, California, United States

Lovelace Scientific Resources, Inc.

Beverly Hills, California, United States

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Advance Care Medical Group

City of Industry, California, United States

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