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

Purdue Pharma LP204 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

204

Conditions

Osteoarthritis

Interventions

Buprenorphine transdermal patchDRUG

Buprenorphine transdermal patch applied for 7-day wear.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (36)

Outcomes

Primary Outcomes

The Percentage of Subjects Who Completed the 14-day Double-blind Phase.

The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs \>22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).

Time frame: 14 days

Data from ClinicalTrials.gov

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