Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Buprenorphine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312572

BUP3018

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

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: 204 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

Exclusion criteria

• currently have condition requiring a stable regimen of acetaminophen (APAP).
• a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.

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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204 participants in 2 patient groups

BTDS10/20

Experimental group

Description:

Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4.

Treatment:

Drug: Buprenorphine transdermal patch

BTDS 20

Experimental group

Description:

Initial doses (Level 1) of BTDS 20.

Treatment:

Drug: Buprenorphine transdermal patch