Status:
COMPLETED
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
Lead Sponsor:
Indivior Inc.
Conditions:
Buprenorphine
Naloxone
Eligibility:
All Genders
Brief 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 Buprenorphi...
Detailed Description
Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
Eligibility Criteria
Inclusion
- 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 of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1307 Patients enrolled
Trial Details
Trial ID
NCT00723697
Start Date
May 1 2007
End Date
February 1 2010
Last Update
March 20 2023
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