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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00312572
First received: April 7, 2006
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Buprenorphine transdermal patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The Percentage of Subjects Who Completed the 14-day Double-blind Phase. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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).


Enrollment: 204
Study Start Date: June 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTDS10/20
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.
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™
Experimental: BTDS 20
Initial doses (Level 1) of BTDS 20.
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312572

  Show 36 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
Publications:
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312572     History of Changes
Other Study ID Numbers: BUP3018
Study First Received: April 7, 2006
Results First Received: July 29, 2010
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Osteoarthritis, opioid, transdermal

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014