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

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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: Buprenorphine
Drug: Codeine paracetamol

  Participant Flow

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 
Other                6                13 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 
[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.
Gender 
[Units: Participants]
 		     
Female   75   74   149 
Male   35   35   70 


  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


  Other Adverse Events

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 



  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.


  More Information