Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

This study has been completed.

Study NCT00312572 Information provided by Purdue Pharma LP

First Received on April 7, 2006. Last Updated on December 2, 2010 History of Changes

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:	Osteoarthritis
Intervention:	Drug: Buprenorphine transdermal patch

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: 26-Jun-2003 (first patient first visit) to 21-Jul-2004 (last patient last visit) in 29 medical/research centers in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily “average pain over the last 24 hours” score of 0=none or 1=mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.

Reporting Groups

	Description
Double-blind BTDS 10/20	Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
Double-blind BTDS 20	Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.

Participant Flow: Overall Study

	Double-blind BTDS 10/20	Double-blind BTDS 20
STARTED	101	103
COMPLETED	85	82
NOT COMPLETED	16	21
Adverse Event	10	16
Lost to Follow-up	1	1
Administrative	4	2
Lack of Efficacy	1	2

Baseline Characteristics

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Reporting Groups

	Description
Double-blind BTDS 10/20	Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
Double-blind BTDS 20	Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.

Baseline Measures

	Double-blind BTDS 10/20	Double-blind BTDS 20	Total
Number of Participants [units: participants]	101	103	204
Age [units: years] Mean ± Standard Deviation	57.4 ± 10.10	58.9 ± 9.97	58.2 ± 10.04
Gender [units: participants]
Female	63	73	136
Male	38	30	68

Outcome Measures

1. Primary:

The Percentage of Subjects Who Completed the 14-day Double-blind Phase. [ Time Frame: 14 days ]

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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
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Results Point of Contact:

Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
phone: 800-733-1333

No publications provided

Responsible Party:	Medical Monitor, Purdue Pharma L.P.
ClinicalTrials.gov Identifier:	NCT00312572 History of Changes
Other Study ID Numbers:	BUP3018
Study First Received:	April 7, 2006
Results First Received:	July 29, 2010
Last Updated:	December 2, 2010
Health Authority:	United States: Food and Drug Administration