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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Buprenorphine transdermal patch

• Registration Number: NCT00312572
• Lead Sponsor: Purdue Pharma LP

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2006-04-07
• Study First Submitted QC: 2006-04-07
• Study First Posted: 2006-04-10
• Results First Submitted: 2010-07-29
• Results First Submitted QC: 2010-09-01
• Results First Posted: 2010-09-23
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTDS 20	Buprenorphine transdermal patch	Initial doses (Level 1) of BTDS 20.
BTDS10/20	Buprenorphine transdermal patch	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.

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects Who Completed the 14-day Double-blind Phase.	14 days	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).

Trial Locations

Locations (36)

Southern Drug Research; 🇺🇸 Birmingham, Alabama, United States

Redpoint Research; 🇺🇸 Phoenix, Arizona, United States

Advanced Clinical Therapeutics; 🇺🇸 Tucson, Arizona, United States

Tucson Orthopedic Institute; 🇺🇸 Tucson, Arizona, United States

Hot Springs Mercy Pain Clinic; 🇺🇸 Hot Springs, Arkansas, United States

Private Practice; 🇺🇸 Pine Bluff, Arkansas, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Lovelace Scientific Resources; 🇺🇸 Beverly Hills, California, United States

Southbay Pharma Research; 🇺🇸 Buena Park, California, United States

Community Medical Providers; 🇺🇸 Clovis, California, United States

Scroll for more (26 remaining)