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

This study has been terminated.

( Terminated early due to administrative reasons unrelated to efficacy or safety. )

Study NCT00313014 Information provided by Purdue Pharma LP

First Received on April 10, 2006. Last Updated on November 15, 2011 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, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Chronic Low Back Pain
Interventions:	Drug: Buprenorphine Drug: Oxycodone Immediate-Release

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
The study began with first patient first visit (FPFV) on 25-Feb-2004 to last patient last visit (LPLV) on 23-Sep-2005, at 75 medical/research sites in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prerandomization: screening period [Prospective assessment: subjects were assessed to ensure compliance with all inclusion/exclusion criteria]. Opioid taper segment: assessed the severity of the subject’s low back pain upon analgesic medication discontinuation. Open-label run-in period: identified subjects whose pain was controlled with BTDS 20.

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 HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Participant Flow: Overall Study

	Double-blind BTDS 5	Double-blind BTDS 20	Double-blind Oxycodone Immediate-Release
STARTED	221	219	220
COMPLETED	128	146	159
NOT COMPLETED	93	73	61
Withdrawal by Subject	11	7	5
Adverse Event	14	29	16
Lost to Follow-up	7	6	10
Administrative	9	6	14
Lack of Efficacy	52	25	16

Baseline Characteristics

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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 HCl 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]	221	219	220	660
Age [units: years] Mean ± Standard Deviation	50.2 ± 12.88	50.4 ± 11.93	49.5 ± 12.37	50.0 ± 12.39
Gender [units: participants]
Female	101	113	100	314
Male	120	106	120	346

Outcome Measures

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1. Primary:

Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. [ Time Frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase ]

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2. Secondary:

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

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3. Secondary:

Oswestry Disability Index (ODI) Score (V 2.0) [ Time Frame: Weeks 4, 8, 12 ]

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4. Secondary:

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

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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
BUP3015 was terminated early due to administrative reasons unrelated to efficacy or safety.

Results Point of Contact:

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

Publications of Results:

Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and Safety of Buprenorphine Transdermal System (BTDS) for Chronic Moderate to Severe Low Back Pain: A Randomized, Double-Blind Study. J Pain. 2011 Jul 30; [Epub ahead of print]

Responsible Party:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00313014 History of Changes
Other Study ID Numbers:	BUP3015
Study First Received:	April 10, 2006
Results First Received:	July 28, 2010
Last Updated:	November 15, 2011
Health Authority:	United States: Food and Drug Administration