The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. (BP96-0604)

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: Back Pain

Treatments: Drug: Placebo oxycodone/acetaminophen tablets; Drug: Placebo transdermal patch (TDS); Drug: Buprenorphine transdermal patch; Drug: OXY/APAP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00315445

BP96-0604

Details and patient eligibility

About

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Full description

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
• unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

Exclusion criteria

• receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
• scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20

Treatment:

Drug: Placebo transdermal patch (TDS)

Drug: Placebo oxycodone/acetaminophen tablets

OXY/APAP

Active Comparator group

Description:

5 mg oxycodone/325 mg acetaminophen tablets

Treatment:

Drug: OXY/APAP

BTDS

Experimental group

Description:

Buprenorphine transdermal patch 5, 10, or 20 mcg/hour

Treatment:

Drug: Buprenorphine transdermal patch