Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

This study has been terminated.

( Administrative reasons. )

Study NCT00315458 Information provided by Purdue Pharma LP

First Received on April 17, 2006. Last Updated on December 2, 2010 History of Changes

Results First Received: July 28, 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
Interventions:	Drug: Buprenorphine transdermal patch Drug: Placebo transdermal patch

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12-Dec-2003 (First Patient First Visit) 02-Mar-2005 (Last Patient Last Visit of Extension). At the time of early termination, 39 centers had screened subjects, 22 centers had randomized subjects to the double-blind phase.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects (N = 159) in the run-in period received BTDS 5 for the first 3 days, titrated to BTDS 10 or 20, continued stable nonopioid analgesic regimen for osteoarthritis (OA) pain, and took oxycodone immediate-release 5-mg capsules as supplemental analgesic therapy for primary OA pain site. N = 107 completed the run-in and were randomized.

Reporting Groups

	Description
Double-blind Placebo Patch	Reference Treatment placebo 10 or 20 applied for 7-day wear
Double-blind BTDS 10/20	Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
Run-in Period BTDS 5/10/20	All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
Extension Phase BTDS 5/10/20	Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed.

Participant Flow: Overall Study

	Double-blind Placebo Patch	Double-blind BTDS 10/20	Run-in Period BTDS 5/10/20	Extension Phase BTDS 5/10/20
STARTED	51	56	159	39
COMPLETED	48	44	107	10
NOT COMPLETED	3	12	52	29
Administrative	0	3	8	21
Adverse Event	2	4	23	3
Lost to Follow-up	1	2	0	2
Withdrawal by Subject	0	3	0	2
Lack of Efficacy	0	0	20	1
Did not qualify	0	0	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Double-blind Placebo Patch	Reference Treatment placebo 10 or 20 applied for 7-day wear
Double-blind BTDS	Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear

Baseline Measures

	Double-blind Placebo Patch	Double-blind BTDS	Total
Number of Participants [units: participants]	51	56	107
Age [units: years] Mean ± Standard Deviation	61.2 ± 11.36	59.4 ± 9.56	60.3 ± 10.45
Gender [units: participants]
Female	33	39	72
Male	18	17	35

Outcome Measures

1. Primary:

Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: 483 days ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
This study was terminated early for administrative reasons. The efficacy data are not presented since the primary objective of this study was changed identifying it as a safety study.

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:	Medical Monitor, Purdue Pharma L.P.
ClinicalTrials.gov Identifier:	NCT00315458 History of Changes
Obsolete Identifiers:	NCT01137279
Other Study ID Numbers:	BUP3011 and BUP3011S
Study First Received:	April 17, 2006
Results First Received:	July 28, 2010
Last Updated:	December 2, 2010
Health Authority:	United States: Food and Drug Administration