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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

This study has been completed.
Sponsor:
Collaborator:
Napp Pharmaceuticals Limited
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00312195
First received: April 5, 2006
Last updated: September 5, 2012
Last verified: September 2012
Results First Received: July 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Non-malignant Pain
Interventions: Drug: Buprenorphine transdermal patch
Drug: Placebo to match BTDS

  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
(First patient first visit) 19-Mar-2001 to (last patient last visit) 22-Jul-2001 at 42 centers: 21 in the UK and 21 in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Run-in period (N = 588 subjects started) consisted of titration from buprenorphine transdermal patch (BTDS) 5 to BTDS 10, or 20 mcg/h for tolerability. If BTDS was not tolerated or pain increased, the subject was discontinued. N = 267 subjects were randomized.

Reporting Groups
  Description
Double-blind Placebo Patch Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
Double-blind BTDS Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.

Participant Flow:   Overall Study
    Double-blind Placebo Patch     Double-blind BTDS  
STARTED     138     129  
COMPLETED     132     123  
NOT COMPLETED     6     6  
Adverse Event                 4                 6  
Lost to Follow-up                 1                 0  
Protocol Violation                 1                 0  



  Baseline Characteristics
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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
Double-blind Placebo Patch Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
Double-blind BTDS Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
Total Total of all reporting groups

Baseline Measures
    Double-blind Placebo Patch     Double-blind BTDS     Total  
Number of Participants  
[units: participants]
  138     129     267  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 11.48     56.2  ± 13.34     57.7  ± 12.48  
Gender  
[units: participants]
     
Female     88     79     167  
Male     50     50     100  
Region of Enrollment  
[units: participants]
     
United States     46     42     88  
United Kingdom     92     87     179  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.   [ Time Frame: Double-blind phase (14 days) ]

2.  Secondary:   Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment   [ Time Frame: 14 days ]

3.  Secondary:   The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase   [ Time Frame: 14 days ]

4.  Secondary:   The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).   [ Time Frame: 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


No publications provided


Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312195     History of Changes
Other Study ID Numbers: BUP3201
Study First Received: April 5, 2006
Results First Received: July 29, 2010
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration