The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. (BP96-0604)

This study has been completed.
Sponsor:
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00315445
First received: April 17, 2006
Last updated: August 27, 2012
Last verified: August 2012
Results First Received: May 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Back Pain
Interventions: Drug: Buprenorphine transdermal patch
Drug: Placebo oxycodone/acetaminophen tablets
Drug: OXY/APAP
Drug: Placebo transdermal patch (TDS)

  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
10-Dec-1997 (first subject, first visit) to 08-May-1998 (last subject last visit) in 13 centers in the United States

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study was designed to evaluate the efficacy and safety of BTDS in comparison with current pharmacotherapeutic pain management practice and placebo in opioid-naïve or opioid-experienced adult subjects with chronic back pain not manageable with nonopioid analgesics alone (range, 19–85 years).

Reporting Groups
  Description
Placebo Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
OXY/APAP 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
BTDS Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.

Participant Flow:   Overall Study
    Placebo     OXY/APAP     BTDS  
STARTED     45     43     46  
COMPLETED     18     27     22  
NOT COMPLETED     27     16     24  
Adverse Event                 7                 12                 15  
Lack of Efficacy                 16                 1                 7  
Lost to Follow-up                 1                 0                 1  
Protocol Violation                 2                 0                 1  
unknown                 1                 3                 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
Placebo Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
OXY/APAP 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
BTDS Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Total Total of all reporting groups

Baseline Measures
    Placebo     OXY/APAP     BTDS     Total  
Number of Participants  
[units: participants]
  45     43     46     134  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 2.2     49  ± 2.5     54  ± 2.2     52  ± 1.31  
Gender  
[units: participants]
       
Female     25     27     28     80  
Male     20     16     18     54  
Opioid Experience [1]
[units: participants]
       
Opioid naive     39     34     34     107  
Opioid experienced     6     9     12     27  
[1] Subjects were either classified as "opioid naive" (those not currently receiving an opioid-containing analgesic or those receiving 2 or fewer short-acting opioid tablets or capsules per day) or "opioid experienced" (those receiving a controlled-release opioid analgesic at a dose of ≤ 90 mg of morphine equivalents per day or those receiving 3 to 12 capsules or tablets of short-acting opioid analgesics per day)



  Outcome Measures
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1.  Primary:   Pain on the Average, Mean Change From Baseline Days 21–84 (Last Observation Carried Forward [LOCF])   [ Time Frame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. ]

2.  Primary:   Pain Right Now, Mean Change From Baseline, Days 21–84 (LOCF)   [ Time Frame: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. ]

3.  Secondary:   "Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)   [ Time Frame: Day 84, or, if applicable, at early termination ]

4.  Secondary:   "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)   [ Time Frame: Day 84 ]

5.  Secondary:   "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)   [ Time Frame: Day 84 ]

6.  Secondary:   "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)   [ Time Frame: Day 84 ]

7.  Secondary:   "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)   [ Time Frame: Day 84 ]

8.  Secondary:   "Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)   [ Time Frame: Day 84 ]

9.  Secondary:   "Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)   [ Time Frame: Day 84 ]

10.  Secondary:   "Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)   [ Time Frame: Day 84 ]

11.  Secondary:   Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)   [ Time Frame: Day 84 ]

12.  Secondary:   Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)   [ Time Frame: Day 84 ]

13.  Secondary:   Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)   [ Time Frame: Day 84 ]

14.  Secondary:   Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)   [ Time Frame: Day 84 ]

15.  Secondary:   Time to Stable Pain Management   [ Time Frame: Start of study to day 21. ]

16.  Secondary:   The Time to Discontinuation Due to Lack of Efficacy   [ Time Frame: Time after dosing to dropout due to lack of efficacy ]

17.  Post-Hoc:   Sensitivity Analysis: “Pain on the Average” Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)   [ Time Frame: Baseline to days 21 - 84 ]

18.  Post-Hoc:   Sensitivity Analysis: “Pain Right Now” Change From Baseline in the Maintenance Period (Days 21–84), BOCF   [ Time Frame: Baseline to days 21-84 ]

19.  Post-Hoc:   Sensitivity Analysis "Pain on the Average" Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)   [ Time Frame: Baseline to days 21-84 ]

20.  Post-Hoc:   Sensitivity Analysis: "Pain Right Now" Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)   [ Time Frame: Baseline to days 21-84 ]

21.  Post-Hoc:   Sensitivity Analysis: "Pain on the Average" Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)   [ Time Frame: Baseline to day 84 ]

22.  Post-Hoc:   Sensitivity Analysis: "Pain Right Now" Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)   [ Time Frame: Baseline to day 84 ]


  Serious Adverse Events


  Other Adverse Events


  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
There was a large percentage of discontinuations across treatment groups.  


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


No publications provided


Responsible Party: Medical Director, Medical Research, Purdue Pharma L.P.
ClinicalTrials.gov Identifier: NCT00315445     History of Changes
Other Study ID Numbers: BP96-0604
Study First Received: April 17, 2006
Results First Received: May 17, 2011
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration