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A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00605033
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : June 30, 2010
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Opiate Dependence
Drug Dependence
Interventions Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444
Enrollment 241
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Suboxone Subutex
Hide Arm/Group Description Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2. Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Period Title: Overall Study
Started 143 98 [1]
Completed 136 90
Not Completed 7 8
Reason Not Completed
Adverse Event             2             2
Lost to Follow-up             1             1
Withdrawal by Subject             3             4
Protocol Violation             1             1
[1]
One participant was randomized but withdrew before taking any study medication (treated n=97).
Arm/Group Title Suboxone Subutex Total
Hide Arm/Group Description Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2. Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2. Total of all reporting groups
Overall Number of Baseline Participants 143 97 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 143 participants 97 participants 240 participants
35.8  (8.2) 35.5  (8.7) 35.7  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 97 participants 240 participants
Female
30
  21.0%
22
  22.7%
52
  21.7%
Male
113
  79.0%
75
  77.3%
188
  78.3%
1.Primary Outcome
Title Response Rate
Hide Description Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.
Time Frame Assessed by Day 7 of double-blind, double-dummy treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of primary outcome was done on the intention-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and provided at least one valid post-baseline assessment.
Arm/Group Title Suboxone Subutex
Hide Arm/Group Description:
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Overall Number of Participants Analyzed 143 97
Measure Type: Number
Unit of Measure: Percentage of participants
83.2 88.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Suboxone, Subutex
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was defined as a lower bound of the two-sided 95% confidence interval of the proportion difference greater than -0.15.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value -0.054
Confidence Interval (2-Sided) 95%
-0.142 to 0.034
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Suboxone Subutex
Hide Arm/Group Description Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2. Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
All-Cause Mortality
Suboxone Subutex
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Suboxone Subutex
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/143 (1.40%)      4/97 (4.12%)    
Blood and lymphatic system disorders     
Normochromic normocytic anaemia  1  0/143 (0.00%)  0 1/97 (1.03%)  1
Gastrointestinal disorders     
Melaena  1  0/143 (0.00%)  0 1/97 (1.03%)  1
Infections and infestations     
Pneumonia  1  0/143 (0.00%)  0 1/97 (1.03%)  1
Injury, poisoning and procedural complications     
Road traffic accident  1  0/143 (0.00%)  0 1/97 (1.03%)  1
Nervous system disorders     
Coma  1  1/143 (0.70%)  1 0/97 (0.00%)  0
Epilepsy  1  1/143 (0.70%)  1 1/97 (1.03%)  1
Psychiatric disorders     
Suicide attempt  1  1/143 (0.70%)  1 0/97 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/143 (0.00%)  0 1/97 (1.03%)  1
Surgical and medical procedures     
Drug detoxification  1  0/143 (0.00%)  0 1/97 (1.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Suboxone Subutex
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/143 (55.24%)      52/97 (53.61%)    
Eye disorders     
Lacrimation increased  1  9/143 (6.29%)  9 1/97 (1.03%)  1
Gastrointestinal disorders     
Abdominal pain upper  1  9/143 (6.29%)  14 4/97 (4.12%)  5
Diarrhoea  1  8/143 (5.59%)  8 1/97 (1.03%)  1
Nausea  1  21/143 (14.69%)  29 7/97 (7.22%)  8
Toothache  1  1/143 (0.70%)  1 5/97 (5.15%)  5
General disorders     
Asthenia  1  12/143 (8.39%)  15 7/97 (7.22%)  8
Chills  1  10/143 (6.99%)  11 7/97 (7.22%)  7
Fatigue  1  7/143 (4.90%)  8 5/97 (5.15%)  5
Musculoskeletal and connective tissue disorders     
Myalgia  1  8/143 (5.59%)  9 7/97 (7.22%)  7
Nervous system disorders     
Headache  1  23/143 (16.08%)  30 12/97 (12.37%)  15
Psychiatric disorders     
Anxiety  1  23/143 (16.08%)  27 16/97 (16.49%)  17
Drug dependence  1  10/143 (6.99%)  11 4/97 (4.12%)  6
Restlessness  1  6/143 (4.20%)  6 5/97 (5.15%)  5
Insomnia  1  12/143 (8.39%)  12 10/97 (10.31%)  13
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea  1  15/143 (10.49%)  16 6/97 (6.19%)  6
Yawning  1  12/143 (8.39%)  12 5/97 (5.15%)  5
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  18/143 (12.59%)  28 9/97 (9.28%)  11
Piloerection  1  9/143 (6.29%)  10 2/97 (2.06%)  3
Vascular disorders     
Hot flush  1  10/143 (6.99%)  12 5/97 (5.15%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
Investigator will publish/present results together with other study sites, unless written permission is obtained from Sponsor. Investigator provides 45 days' written notice to Sponsor prior to submission for publication/presentation so that Sponsor can review copies of abstracts/manuscripts reporting results. Sponsor has the right to review/comment on any presentation regarding proprietary information, accuracy and fair balance of the information, and compliance with FDA regulations.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
EMail: ClinicalTrialsDisclosure@spcorp.com
Layout table for additonal information
Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00605033     History of Changes
Other Study ID Numbers: P04843
SWITCH
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: May 27, 2010
Results First Posted: June 30, 2010
Last Update Posted: October 21, 2016