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

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: Buprenorphine transdermal system; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00490919

BUP3024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 539 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

539 participants in 2 patient groups, including a placebo group

Double-blind BTDS 10 or 20

Experimental group

Description:

Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear

Treatment:

Drug: Buprenorphine transdermal system

Double-blind Placebo TDS

Placebo Comparator group

Description:

Placebo transdermal system to match BTDS patches, applied for 7 days

Treatment:

Drug: Placebo