Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

Purdue Pharma

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: oxycodone immediate-release; Drug: Buprenorphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312221

BUP3019

Details and patient eligibility

About

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to 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: 418 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
• Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.

Exclusion criteria

• Not currently taking and tolerating opioids.
• Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
• Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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418 participants in 3 patient groups

BTDS 5

Active Comparator group

Description:

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

Treatment:

Drug: Buprenorphine

Drug: Buprenorphine

BTDS 20

Experimental group

Description:

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Treatment:

Drug: Buprenorphine

Drug: Buprenorphine

Oxycodone Immediate-Release (Oxy IR) 40 mg

Experimental group

Description:

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Treatment:

Drug: oxycodone immediate-release