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

This study has been completed.
Sponsor:
Information provided by:
Napp Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00324038
First received: May 9, 2006
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
Results First Received: July 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: Buprenorphine
Drug: Codeine paracetamol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Primary care. March 2006 to Aug 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for patient eligibility

Reporting Groups
  Description
Buprenorphine Transdermal System Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
Co-codamol Tablets combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500

Participant Flow:   Overall Study
    Buprenorphine Transdermal System     Co-codamol Tablets  
STARTED     110     109  
COMPLETED     61     58  
NOT COMPLETED     49     51  
Adverse Event                 38                 23  
Lack of Efficacy                 5                 13  
Lost to Follow-up                 0                 2  
Unknown                 6                 13  



  Baseline Characteristics
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Reporting Groups
  Description
Buprenorphine Transdermal System Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
Co-codamol Tablets combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Total Total of all reporting groups

Baseline Measures
    Buprenorphine Transdermal System     Co-codamol Tablets     Total  
Number of Participants  
[units: participants]
 		  110     109     219  
Age [1]
[units: particpants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     20     23     43  
>=65 years     90     86     176  
Gender  
[units: participants]
 		     
Female     75     74     149  
Male     35     35     70  
[1] Subjects over 60 years of age were recruited into the study. Initially study started with recruitment age of 65 but this was lowered by protocol amendment to 60 years of age.



  Outcome Measures

1.  Primary:   Average Daily Pain Scores - BS11 Pain Scores.   [ Time Frame: every day over a 12 week study duration. ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description Serious and non serious adverse events were collected/assessed but not serious adverse events

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Buprenorphine Transdermal System Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
Co-codamol Tablets 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 Adverse Events
    Buprenorphine Transdermal System     Co-codamol Tablets  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/0     0/0  



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr Paul Schofield, Medical Director
Organization: Napp Pharmaceutical Ltd
phone: 01223424444
e-mail: info@contact-clinical-trials.com


No publications provided by Napp Pharmaceuticals Limited

Publications automatically indexed to this study:


Responsible Party: Dr J Paul Schofield, Napp Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00324038     History of Changes
Other Study ID Numbers: 2005-004279-39, BUP4004
Study First Received: May 9, 2006
Results First Received: July 17, 2009
Last Updated: June 13, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency