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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
Enrollment 219
Recruitment Details Primary care. March 2006 to Aug 2007
Pre-assignment Details Screening for patient eligibility
Arm/Group Title Buprenorphine Transdermal System Co-codamol Tablets
Hide Arm/Group Description Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Period Title: Overall Study
Started 110 109
Completed 61 58
Not Completed 49 51
Reason Not Completed
Adverse Event             38             23
Lack of Efficacy             5             13
Lost to Follow-up             0             2
Other             6             13
Arm/Group Title Buprenorphine Transdermal System Co-codamol Tablets Total
Hide Arm/Group Description Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days 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 of all reporting groups
Overall Number of Baseline Participants 110 109 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 109 participants 219 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  18.2%
23
  21.1%
43
  19.6%
>=65 years
90
  81.8%
86
  78.9%
176
  80.4%
[1]
Measure Description: 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.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 109 participants 219 participants
Female
75
  68.2%
74
  67.9%
149
  68.0%
Male
35
  31.8%
35
  32.1%
70
  32.0%
1.Primary Outcome
Title Average Daily Pain Scores - BS11 Pain Scores.
Hide Description 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.
Time Frame every day over a 12 week study duration.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine Transdermal System Co-codamol Tablets
Hide Arm/Group Description:
Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Overall Number of Participants Analyzed 61 58
Mean (Standard Deviation)
Unit of Measure: Box Scale 11 boxes
3  (1.31) 3  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and non serious adverse events were collected/assessed but not serious adverse events
 
Arm/Group Title Buprenorphine Transdermal System Co-codamol Tablets
Hide Arm/Group Description Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
All-Cause Mortality
Buprenorphine Transdermal System Co-codamol Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine Transdermal System Co-codamol Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Buprenorphine Transdermal System Co-codamol Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Paul Schofield, Medical Director
Organization: Napp Pharmaceutical Ltd
Phone: 01223424444
EMail: info@contact-clinical-trials.com
Layout table for additonal information
Responsible Party: Dr J Paul Schofield, Napp Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00324038     History of Changes
Other Study ID Numbers: 2005-004279-39
BUP4004
First Submitted: May 9, 2006
First Posted: May 10, 2006
Results First Submitted: July 17, 2009
Results First Posted: March 30, 2010
Last Update Posted: June 14, 2011