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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

This study has been terminated.
(terminated early for administrative reasons unrelated to safety or efficacy)
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00312221
First received: April 6, 2006
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
Results First Received: July 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: Buprenorphine
Drug: oxycodone immediate-release

  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
Study Dates: 02-Apr-2004 (first subject first visit) to 18 Jul-2005 (last subject last visit); 15-Jun-2005 (first site notified of study termination). The study took place in 82 medical/research sites in the US; 59 sites randomized at least 1 subject.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Men and women aged 40 years or older with OA of the hip, knee, or spine, on 30 to 80 mg/day morphine sulfate (MSO4) or equivalent, with or without nonopioid analgesic medication. (652 subjects entered the run-in period; 418 completed.) Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.

Reporting Groups
  Description
Run-in Period The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
Double-blind BTDS 5 Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Double-blind BTDS 20 Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Double-blind Oxycodone Immediate-Release Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Participant Flow for 2 periods

 Period 1:   Open-label Run-in Period
    Run-in Period     Double-blind BTDS 5     Double-blind BTDS 20     Double-blind Oxycodone Immediate-Release  
STARTED     652     0     0     0  
COMPLETED     418     0     0     0  
NOT COMPLETED     234     0     0     0  
Withdrawal by Subject                 6                 0                 0                 0  
Adverse Event                 74                 0                 0                 0  
Lost to Follow-up                 5                 0                 0                 0  
Administrative                 42                 0                 0                 0  
Lack of Efficacy                 102                 0                 0                 0  
Did not qualify                 5                 0                 0                 0  

Period 2:   Double-blind Phase
    Run-in Period     Double-blind BTDS 5     Double-blind BTDS 20     Double-blind Oxycodone Immediate-Release  
STARTED     0     136     149     133  
COMPLETED     0     77     77     63  
NOT COMPLETED     0     59     72     70  
Withdrawal by Subject                 0                 6                 8                 7  
Adverse Event                 0                 10                 19                 18  
Lost to Follow-up                 0                 0                 2                 2  
Administrative                 0                 26                 37                 33  
Lack of Efficacy                 0                 17                 6                 10  



  Baseline Characteristics
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Reporting Groups
  Description
Double-blind BTDS 5 Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Double-blind BTDS 20 Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Double-blind Oxycodone Immediate-Release Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Total Total of all reporting groups

Baseline Measures
    Double-blind BTDS 5     Double-blind BTDS 20     Double-blind Oxycodone Immediate-Release     Total  
Number of Participants  
[units: participants]
 		  136     149     133     418  
Age  
[units: years]
Mean ± Standard Deviation 		  58.7  ± 10.71     57.9  ± 9.45     58.1  ± 10.36     58.3  ± 10.15  
Gender  
[units: participants]
 		       
Female     101     116     94     311  
Male     35     33     39     107  



  Outcome Measures
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1.  Primary:   “Average Pain Over the Last 24 Hours” Scores at Weeks 4, 8, and 12 of the Double-blind Phase.   [ Time Frame: Weeks 4, 8, and 12 of the double-blind phase ]
  Show Outcome Measure 1

2.  Secondary:   The Mean Daily Number of Supplemental Analgesic Medication Tablets   [ Time Frame: Double-blind phase (84 days) ]
  Show Outcome Measure 2

3.  Secondary:   The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase   [ Time Frame: Weeks 4, 8 and 12 of the double-blind phase ]
  Show Outcome Measure 3

4.  Secondary:   The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase   [ Time Frame: Weeks 4, 8, and 12 of the Double-blind Phase ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
This study was terminated early for administrative reasons not related to safety or efficacy. Low enrollment at termination led to reduced power.  


Results Point of Contact:  
Name/Title: Clinical Leader, Medical Director
Organization: Purdue Pharma L.P.
phone: 800-733-1333


No publications provided


Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312221     History of Changes
Other Study ID Numbers: BUP3019
Study First Received: April 6, 2006
Results First Received: July 15, 2010
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration