Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Placebo; Drug: Buprenorphine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313846

BUP3012

Details and patient eligibility

About

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) 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 situations for the relief of moderate to severe pain.

Enrollment: 529 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
• an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.

Exclusion criteria

• ingest opioid analgesics on a daily basis.
• ingest >2500 milligrams (mg) acetaminophen on a daily basis.
• require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.

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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529 participants in 2 patient groups, including a placebo group

BTDS

Experimental group

Description:

Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)

Treatment:

Drug: Buprenorphine transdermal patch

Placebo

Placebo Comparator group

Description:

Placebo to match BTDS 5, 10 or 20 mcg/h

Treatment:

Drug: Placebo