Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

This study has been completed.

Study NCT00531427 Information provided by Purdue Pharma LP

First Received on September 17, 2007. Last Updated on February 9, 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
Conditions:	Chronic Pain Osteoarthritis of the Knee
Interventions:	Drug: Buprenorphine Drug: Placebo

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
27-Sep-2007 (first patient first visit) to 28-Apr-2009 (last patient last visit) at 83 medical/research sites in US

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open-label run-in period designed to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). N = 1151 entered the run-in period, and N = 571 completed. One subject was not dosed, therefore N = 570 randomized. N = 3 subjects did not have safety data, therefore N = 567 had double-blind data.

Reporting Groups

	Description
Double-blind BTDS 10 or 20	Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
Double-blind Placebo	Placebo patches to match the BTDS patches applied for 7-day wear

Participant Flow: Overall Study

	Double-blind BTDS 10 or 20	Double-blind Placebo
STARTED	282	285
COMPLETED	209	191
NOT COMPLETED	73	94
Withdrawal by Subject	7	13
Adverse Event	44	30
Lost to Follow-up	4	3
Lack of Efficacy	14	39
Administrative	4	9

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Double-blind BTDS 10 or 20	Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
Double-blind Placebo	Placebo patches to match the BTDS patches applied for 7-day wear

Baseline Measures

	Double-blind BTDS 10 or 20	Double-blind Placebo	Total
Number of Participants [units: participants]	282	285	567
Age [units: years] Mean ± Standard Deviation	59.1 ± 9.75	59.1 ± 9.77	59.1 ± 9.75
Gender [units: participants]
Female	175	181	356
Male	107	104	211

Outcome Measures

Show All Outcome Measures

1. Primary:

"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. [ Time Frame: 24 hours (week 12) ]

Show Outcome Measure 1

2. Secondary:

Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. [ Time Frame: 10 weeks ]

Show Outcome Measure 2

3. Secondary:

Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase. [ Time Frame: Weeks 4, 8, and 12 of the double-bind phase ]

Show Outcome Measure 3

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
No text entered.

Results Point of Contact:

Name/Title: Clinical Leader, Executive Medical Director
Organization: Purdue Pharma
phone: 800-733-1333

No publications provided

Responsible Party:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00531427 History of Changes
Other Study ID Numbers:	BUP3025
Study First Received:	September 17, 2007
Results First Received:	July 28, 2010
Last Updated:	February 9, 2012
Health Authority:	United States: Food and Drug Administration