Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain

This study has been completed.

Study NCT00490919 Information provided by Purdue Pharma LP

First Received on June 21, 2007. Last Updated on October 5, 2011 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, Investigator); Primary Purpose: Treatment
Condition:	Low Back Pain
Interventions:	Drug: Buprenorphine transdermal system Drug: Placebo

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
Study dates: 27-Jun-2007 (first patient first visit) to 24-Jul-2008 (last patient last visit), at 86 medical/research sites in the USA.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The open-label run-in period (N = 1024 started) was designed to select subjects for randomization in the double-blind phase who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).

Reporting Groups

	Description
Open-label Run-in Period	The open-label run-in period (< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design). Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population.
Double-blind BTDS 10 or 20	Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
Double-blind Placebo TDS	Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.

Description

Open-label Run-in Period

The open-label run-in period (< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).

Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population.

Double-blind BTDS 10 or 20

Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.

Double-blind Placebo TDS

Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.

Participant Flow for 2 periods

Period 1: Open-label Run-in Period

	Open-label Run-in Period	Double-blind BTDS 10 or 20	Double-blind Placebo TDS
STARTED	1024	0	0
COMPLETED	541 ^[1]	0	0
NOT COMPLETED	483	0	0
Adverse Event	239	0	0
Withdrawal by Subject	37	0	0
Lost to Follow-up	21	0	0
Lack of Efficacy	143	0	0
Administrative	40	0	0
Confirmed or suspected diversion	3	0	0

[1]	Completed run-in and randomized; however 2 had no safety data after randomization visit (N = 539)

Period 2: Double-blind Phase

	Double-blind BTDS 10 or 20	Double-blind Placebo TDS
STARTED	256 ^[1]	283 ^[1]
COMPLETED	170	199
NOT COMPLETED	86	84
Adverse Event	40	20
Withdrawal by Subject	10	11
Lost to Follow-up	8	11
Lack of Efficacy	22	36
Administrative	6	6

[1]	1 subject had no safety data in DB phase; therefore is excluded from randomized safety population.

Baseline Characteristics

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Reporting Groups

	Description
Double-blind BTDS	Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
Double-blind Placebo TDS	Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase

Baseline Measures

	Double-blind BTDS	Double-blind Placebo TDS	Total
Number of Participants [units: participants]	256	283	539
Age [units: years] Mean ± Standard Deviation	48.9 ± 12.50	50.1 ± 13.31	49.5 ± 12.93
Gender [units: participants]
Female	133	163	296
Male	123	120	243

Outcome Measures

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1. Primary:

Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. [ Time Frame: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase. ]

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2. Secondary:

The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase [ Time Frame: weeks 2-12 ]

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3. Secondary:

The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase [ Time Frame: Weeks 4, 8, 12 of 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
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Results Point of Contact:

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

Publications of Results:

Steiner DJ, Sitar S, Wen W, Sawyerr G, Munera C, Ripa SR, Landau C. Efficacy and Safety of the Seven-Day Buprenorphine Transdermal System in Opioid-Naïve Patients with Moderate to Severe Chronic Low Back Pain: An Enriched, Randomized, Double-Blind, Placebo-Controlled Study. J Pain Symptom Manage. 2011 Sep 23; [Epub ahead of print]

Responsible Party:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00490919 History of Changes
Other Study ID Numbers:	BUP3024
Study First Received:	June 21, 2007
Results First Received:	July 15, 2010
Last Updated:	October 5, 2011
Health Authority:	United States: Food and Drug Administration