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Trial record 2 of 6 for:    napp pharmaceuticals

Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly

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: NCT00324038
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : March 30, 2010
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Napp Pharmaceuticals Limited

Tracking Information
First Submitted Date  ICMJE May 9, 2006
First Posted Date  ICMJE May 10, 2006
Results First Submitted Date  ICMJE July 17, 2009
Results First Posted Date  ICMJE March 30, 2010
Last Update Posted Date June 14, 2011
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
Average Daily Pain Scores - BS11 Pain Scores. [ Time Frame: every day over a 12 week study duration. ]
The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
The primary efficacy measure will be the average daily pain score.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
  • Optimum method of titration
  • Escape medication use
  • Sleep scale
  • Laxative use
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
Official Title  ICMJE An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee
Brief Summary The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Buprenorphine
    buprenorphine transdermal system 5, 10 and 20 mg
    Other Name: BuTrans/Norspan
  • Drug: Codeine paracetamol
    combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
    Other Name: Co-codamol tablets
Study Arms  ICMJE
  • Experimental: buprenorphine transdermal system
    Buprenorphine transdermal 7 day analgesic patch
    Intervention: Drug: Buprenorphine
  • Active Comparator: codeine paracetamol tablets
    codeine paracetamol combination tablets
    Intervention: Drug: Codeine paracetamol
Publications * Conaghan PG, O'Brien CM, Wilson M, Schofield JP. Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial. Osteoarthritis Cartilage. 2011 Aug;19(8):930-8. doi: 10.1016/j.joca.2011.03.011. Epub 2011 Apr 6.

*   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: March 17, 2010)
219
Original Enrollment  ICMJE
 (submitted: May 9, 2006)
168
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Either sex aged 65 or above
  • Diagnosis of OA of the hip and/or knee
  • Severe pain requiring step two medication
  • Taking maximum dose of paracetamol

Exclusion Criteria:

  • Painful disease of the joints other than OA
  • Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
  • Subjects taking cyclooxygenase (COX) II selective inhibitors
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (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 Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324038
Other Study ID Numbers  ICMJE 2005-004279-39
BUP4004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr J Paul Schofield, Napp Pharmaceuticals Ltd
Study Sponsor  ICMJE Napp Pharmaceuticals Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prof Philip Conaghan
PRS Account Napp Pharmaceuticals Limited
Verification Date June 2011

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