Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

This study has been completed.

Study NCT00684073 Information provided by Reckitt Benckiser Pharmaceuticals, Inc

First Received on May 22, 2008. Last Updated on April 14, 2011 History of Changes

Results First Received: December 17, 2008

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Opiate-related Disorders Opiate Dependence Drug Abuse
Interventions:	Drug: buprenorphine Drug: buprenorphine/naloxone

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
60 subjects who started selection were the number of subjects who attended the selection visit and signed informed consent

Reporting Groups

	Description
Subutex®/Suboxone®	Subutex® for first two days of study followed by Suboxone® for last 3 days of study

Participant Flow for 2 periods

Period 1: Selection

	Subutex®/Suboxone®
STARTED	60
COMPLETED	53 ^[1]
NOT COMPLETED	7
Selection/non-selection criteria	3
Death	1
noncompliance	1
Lost to Follow-up	1
request of the sponsor	1

[1]	number of subjects who had a Day 1 visit

Period 2: Treatment (Days 1 Through 5)

	Subutex®/Suboxone®
STARTED	53 ^[1]
COMPLETED	52 ^[2]
NOT COMPLETED	1
non-respect of eligibility criteria	1

[1]	number of subjects who had a Day 1 visit
[2]	number of subjects who had a Day 5 visit (and therefore completed study)

Baseline Characteristics

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Reporting Groups

	Description
Subutex®/Suboxone®	Subutex® for first two days of study followed by Suboxone® for last 3 days of study

Baseline Measures

	Subutex®/Suboxone®
Number of Participants [units: participants]	53
Age [units: years] Mean ± Standard Deviation	38.9 ± 8.6
Gender [units: participants]
Female	15
Male	38

Outcome Measures

1. Primary:

Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®). [ Time Frame: Each treatment Day (post-dose on days 1-5) ]

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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. Restriction Description: The sponsor agreement is always necessary before PI publishing or communications. The sponsor can review the communication project during 28 days. The sponsor can require changes to the communication and can extend the embargo.

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: Head, Clinical Trials Registry and Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00684073 History of Changes
Other Study ID Numbers:	P05094, 2006-006686-17
Study First Received:	May 22, 2008
Results First Received:	December 17, 2008
Last Updated:	April 14, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency