Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00723749
First received: July 25, 2008
Last updated: April 26, 2012
Last verified: April 2012
Results First Received: January 11, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Opioid-Related Disorders
Opiate Dependence
Drug Abuse
Intervention: 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
Recruitment of sites: Jan - Dec 2008 (General Practitioners, Out-Patient-Clinics, Clinics) Recruitment of patients: Mar 2008 - Dec 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
384 patients were enrolled, 39 datasets were excluded from analysis because 1) physicians withdraw participation agreement, 2) drop-out of patient or final documentation not available

Reporting Groups
  Description
Suboxone Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Participant Flow:   Overall Study
    Suboxone  
STARTED     345 [1]
COMPLETED     182  
NOT COMPLETED     163  
[1] 384 patients were enrolled, 36 non-eligible datasets were excluded from analysis



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Suboxone Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Baseline Measures
    Suboxone  
Number of Participants  
[units: participants]
  345  
Age  
[units: years]
Mean ± Standard Deviation
  35.2  ± 8.9  
Gender  
[units: participants]
 
Female     81  
Male     264  
Region of Enrollment  
[units: participants]
 
Germany     345  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Retention Rate After 12 Months of Treatment With Suboxone   [ Time Frame: 12 months ]

2.  Secondary:   Dosage of SUBOXONE®   [ Time Frame: Day 1 and Final Assessment (month 12 or time of dropout) ]

3.  Secondary:   Take Home Prescriptions of SUBOXONE®   [ Time Frame: Day 1 and Final Assessment (month 12 or time of dropout) ]

4.  Secondary:   Drug Craving (Subjective Effects of Therapy)   [ Time Frame: Baseline and Final Assessment (month 12 or time of dropout) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Global Medical Director
Organization: RB Pharmaceuticals
phone: +1 (804) 379 1090
e-mail: Tim.Baxter@reckittbenckiser.com


No publications provided


Responsible Party: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00723749     History of Changes
Other Study ID Numbers: P05603
Study First Received: July 25, 2008
Results First Received: January 11, 2012
Last Updated: April 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: National Association of Statutory Health Insurance Physicians
Germany: Federal Association of Company Health Insurance Fund