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Observational Study of Misuse of High Dose Buprenorphine (Subutex� or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)

Information source: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Buprenorphine; Naloxone; Opiate-related Disorders; Opiate Dependence; Drug Abuse

Intervention: buprenorphine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Reckitt Benckiser Pharmaceuticals Inc.

Summary

The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.

Clinical Details

Official title: Etude Observationnelle Prospective de l'Utilisation en Situation Reelle; Prospective Real Situation Observational Study of Subutex or Its Buprenorphine High Dose Generic (BHD) in the Replacement Treatment of Major Opiate Dependence: Following Parameters With Respect to Misuse and Pharmacovigilance

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)

Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.

Secondary outcome: Number of Patients Reporting Clinical Consequences of Engaging in Misuse

Detailed description: Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Eligible patients will be those already having a prescription for Subutex or its BHD

generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician.

- The patient must have been informed orally and in writing via the information notice

and have signed it. Exclusion Criteria:

- Criteria of non-eligibility will be related to the contraindications in the Marketing

Authorization (MA) of Subutex or its BHD generic

Locations and Contacts

Additional Information

Starting date: May 2007
Last updated: April 14, 2011

Page last updated: August 20, 2015

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