Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

This study has been terminated.

(This study was terminated early due to administrative reasons.)

Sponsor:

Information provided by (Responsible Party):

Purdue Pharma LP

ClinicalTrials.gov Identifier:

NCT00320801

First received: April 28, 2006

Last updated: August 27, 2012

Last verified: August 2012

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
Intervention:	Drug: Buprenorphine 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
07-Jan-2004 (First subject first visit); 09-Mar-2005 (last subject last visit of extension [subjects went directly into the extension upon completion of the double-blind phase]) at 42 sites in the United States (US).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Adult subjects (≥ 40 years), with osteoarthritis (OA) of the hip, knee or spine for longer than 1 year, controlled on oral opioid therapy, who met the inclusion/exclusion criteria specified in the protocol. The open-label run-in period (N = 188) selected subjects who tolerated BTDS 20 mcg/h and showed stable pain control (N = 96 completed).

Reporting Groups

	Description
Run-in Period	(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
Double-blind BTDS 5	Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Double-blind BTDS 20	Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Extension Phase	Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.

Participant Flow for 3 periods

Period 1: Open-label Run-in Period

	Run-in Period	Double-blind BTDS 5	Double-blind BTDS 20	Extension Phase
STARTED	188	0	0	0
COMPLETED	96	0	0	0
NOT COMPLETED	92	0	0	0
Withdrawal by Subject	2	0	0	0
Adverse Event	33	0	0	0
Administrative	10	0	0	0
Lack of Efficacy	44	0	0	0
Lost to Follow-up	2	0	0	0
Did not qualify	1	0	0	0

Period 2: Double-blind Phase

	Double-blind BTDS 5	Double-blind BTDS 20
STARTED	47	49
COMPLETED	36	35
NOT COMPLETED	11	14
Withdrawal by Subject	0	1
Adverse Event	2	8
Administrative	0	4
Lack of Efficacy	9	1

Period 3: Extension Phase

	Run-in Period	Double-blind BTDS 5	Double-blind BTDS 20	Extension Phase
STARTED	0	0	0	55
COMPLETED	0	0	0	7
NOT COMPLETED	0	0	0	48
Withdrawal by Subject	0	0	0	6
Adverse Event	0	0	0	8
Administrative	0	0	0	29
Lack of Efficacy	0	0	0	2
Lost to Follow-up	0	0	0	3

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Double-blind BTDS 5	Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Double-blind BTDS 20	Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Total	Total of all reporting groups

Baseline Measures

	Double-blind BTDS 5	Double-blind BTDS 20	Total
Number of Participants [units: participants]	47	49	96
Age [units: years] Mean ± Standard Deviation	58.1 ± 11.65	61.1 ± 11.72	59.6 ± 11.72
Gender [units: participants]
Female	34	28	62
Male	13	21	34

Outcome Measures

1. Primary:

The Number of Participants With Adverse Events (AEs) as a Measure of Safety. [ Time Frame: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase) ]

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
Study terminated due to administrative reasons. The primary objective was changed to a safety study prior to unblinding.

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:	NCT00320801 History of Changes
Obsolete Identifiers:	NCT01137422
Other Study ID Numbers:	BUP3014 and BUP3014S
Study First Received:	April 28, 2006
Results First Received:	July 28, 2010
Last Updated:	August 27, 2012
Health Authority:	United States: Food and Drug Administration

To Top