Treatment of Opioid Dependent Patients With Suboxone: Acceptability and Safety From Real Life Scenario (Study P05603) - Tabular View

Tracking Information

First Received Date ^ICMJE

July 25, 2008

Last Updated Date

November 4, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Retention rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00723749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Circumstances of switching to SUBOXONE® (dosage, frequency of intake, subjective effects Acceptance and tolerance of SUBOXONE® treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Dates From a Real Life Scenario.

Brief Summary

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of substitution treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under everyday conditions.

Detailed Description

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned or indicated.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Opiate-related Disorders
Opiate Dependence
Drug Abuse
Buprenorphine
Naloxone

Intervention ^ICMJE

Drug: Buprenorphine/Naloxone

Study Arms / Comparison Groups

Patients where a substitution therapy with SUBOXONE® is planned or indicated, and who have already been pre-treated with SUBUTEX®, or another substitution medication for at least 6 months.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Exclusion Criteria:

In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00723749

Responsible Party

Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough

Study ID Numbers ^ICMJE

P05603

Study Sponsor ^ICMJE

Schering-Plough

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Schering-Plough

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP