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Trial record 14 of 186 for:    BUPRENORPHINE AND NALOXONE

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

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ClinicalTrials.gov Identifier: NCT00684073
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : January 1, 2010
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Indivior Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Opiate-related Disorders
Opiate Dependence
Drug Abuse
Interventions Drug: buprenorphine
Drug: buprenorphine/naloxone
Enrollment 60
Recruitment Details  
Pre-assignment Details 60 subjects who started selection were the number of subjects who attended the selection visit and signed informed consent
Arm/Group Title Subutex®/Suboxone®
Hide Arm/Group Description Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Period Title: Selection
Started 60
Completed 53 [1]
Not Completed 7
Reason Not Completed
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 Title: Treatment (Days 1 Through 5)
Started 53 [1]
Completed 52 [2]
Not Completed 1
Reason Not Completed
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)
Arm/Group Title Subutex®/Suboxone®
Hide Arm/Group Description Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
38.9  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
15
  28.3%
Male
38
  71.7%
1.Primary Outcome
Title 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®).
Hide Description Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"
Time Frame Each treatment Day (post-dose on days 1-5)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit.
Arm/Group Title Day 1 (Subutex®) Day 2 (Subutex®) Day 3 (Suboxone®) Day 4 (Suboxone®) Day 5 (Suboxone®)
Hide Arm/Group Description:
All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Overall Number of Participants Analyzed 53 53 53 53 53
Mean (Standard Deviation)
Unit of Measure: centimeters
7.04  (2.24) 6.83  (2.18) 7.38  (1.93) 6.89  (2.48) 7.12  (2.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 1 (Subutex®), Day 2 (Subutex®), Day 3 (Suboxone®), Day 4 (Suboxone®), Day 5 (Suboxone®)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments p-value adjusted for treatment only
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.42
Estimation Comments Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subutex®/Suboxone®
Hide Arm/Group Description Subutex® for first two days of study followed by Suboxone® for last 3 days of study
All-Cause Mortality
Subutex®/Suboxone®
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Subutex®/Suboxone®
Affected / at Risk (%) # Events
Total   0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Subutex®/Suboxone®
Affected / at Risk (%) # Events
Total   8/53 (15.09%)    
General disorders   
Fatigue  4/53 (7.55%)  4
Nervous system disorders   
Headache  3/53 (5.66%)  3
Skin and subcutaneous tissue disorders   
Hyperhidrosis  3/53 (5.66%)  3
1
Term from vocabulary, MedDRA (9.1)
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head, Clinical Trials Registry and Results Disclosure Group
Organization: Schering-Plough
EMail: ClinicalTrialsDisclosure@spcorp.com
Layout table for additonal information
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
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: December 17, 2008
Results First Posted: January 1, 2010
Last Update Posted: April 19, 2011