Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00312572
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : September 23, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Tracking Information
First Submitted Date  ICMJE April 7, 2006
First Posted Date  ICMJE April 10, 2006
Results First Submitted Date  ICMJE July 29, 2010
Results First Posted Date  ICMJE September 23, 2010
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE June 2003
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2010)
The Percentage of Subjects Who Completed the 14-day Double-blind Phase. [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2006)
Completion of the 14-day double-blind phase.
Change History Complete list of historical versions of study NCT00312572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2006)
  • Proportion of days a subject had successful analgesia.
  • Rate of premature discontinuation.
  • Mean daily average pain over last 24 hours score.
  • WOMAC Osteoarthritis Index score.
  • Medical Outcome Study Sleep Scale score.
  • Treatment satisfaction survey.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
Official Title  ICMJE A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Buprenorphine transdermal patch
  • Experimental: BTDS 20
    Initial doses (Level 1) of BTDS 20.
    Intervention: Drug: Buprenorphine transdermal patch
Publications * Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 μg/h or 20 μg/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2010)
204
Original Enrollment  ICMJE
 (submitted: April 7, 2006)
200
Actual Study Completion Date  ICMJE July 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00312572
Other Study ID Numbers  ICMJE BUP3018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Purdue Pharma LP
Study Sponsor  ICMJE Purdue Pharma LP
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Purdue Pharma LP
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP