Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

This study has been terminated.

( terminated early for administrative reasons unrelated to safety or efficacy )

Study NCT00312221 Information provided by Purdue Pharma LP

First Received on April 6, 2006. Last Updated on September 15, 2010 History of Changes

Results First Received: July 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Osteoarthritis
Interventions:	Drug: Buprenorphine Drug: oxycodone immediate-release

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
Study Dates: 02-Apr-2004 (first subject first visit) to 18 Jul-2005 (last subject last visit); 15-Jun-2005 (first site notified of study termination). The study took place in 82 medical/research sites in the US; 59 sites randomized at least 1 subject.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Men and women aged 40 years or older with OA of the hip, knee, or spine, on 30 to 80 mg/day morphine sulfate (MSO4) or equivalent, with or without nonopioid analgesic medication. (652 subjects entered the run-in period; 418 completed.) Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.

Reporting Groups

	Description
Run-in Period	The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Double-blind Oxycodone Immediate-Release	Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Participant Flow for 2 periods

Period 1: Open-label Run-in Period

	Run-in Period	Double-blind BTDS 5	Double-blind BTDS 20	Double-blind Oxycodone Immediate-Release
STARTED	652	0	0	0
COMPLETED	418	0	0	0
NOT COMPLETED	234	0	0	0
Withdrawal by Subject	6	0	0	0
Adverse Event	74	0	0	0
Lost to Follow-up	5	0	0	0
Administrative	42	0	0	0
Lack of Efficacy	102	0	0	0
Did not qualify	5	0	0	0

Period 2: Double-blind Phase

	Double-blind BTDS 5	Double-blind BTDS 20	Double-blind Oxycodone Immediate-Release
STARTED	136	149	133
COMPLETED	77	77	63
NOT COMPLETED	59	72	70
Withdrawal by Subject	6	8	7
Adverse Event	10	19	18
Lost to Follow-up	0	2	2
Administrative	26	37	33
Lack of Efficacy	17	6	10

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Double-blind Oxycodone Immediate-Release	Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Baseline Measures

	Double-blind BTDS 5	Double-blind BTDS 20	Double-blind Oxycodone Immediate-Release	Total
Number of Participants [units: participants]	136	149	133	418
Age [units: years] Mean ± Standard Deviation	58.7 ± 10.71	57.9 ± 9.45	58.1 ± 10.36	58.3 ± 10.15
Gender [units: participants]
Female	101	116	94	311
Male	35	33	39	107

Outcome Measures

Show All Outcome Measures

1. Primary:

“Average Pain Over the Last 24 Hours” Scores at Weeks 4, 8, and 12 of the Double-blind Phase. [ Time Frame: Weeks 4, 8, and 12 of the double-blind phase ]

Show Outcome Measure 1

2. Secondary:

The Mean Daily Number of Supplemental Analgesic Medication Tablets [ Time Frame: Double-blind phase (84 days) ]

Show Outcome Measure 2

3. Secondary:

The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase [ Time Frame: Weeks 4, 8 and 12 of the double-blind phase ]

Show Outcome Measure 3

4. Secondary:

The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase [ Time Frame: Weeks 4, 8, and 12 of the Double-blind Phase ]

Show Outcome Measure 4

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 not related to safety or efficacy. Low enrollment at termination led to reduced power.

Results Point of Contact:

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

No publications provided

Responsible Party:	Medical Director, Purdue Pharma L.P.
ClinicalTrials.gov Identifier:	NCT00312221 History of Changes
Other Study ID Numbers:	BUP3019
Study First Received:	April 6, 2006
Results First Received:	July 15, 2010
Last Updated:	September 15, 2010
Health Authority:	United States: Food and Drug Administration