Trials / Completed
CompletedNCT00723697
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,307 (actual)
- Sponsor
- Indivior Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | buprenorphine | 0.4, 2, or 8 mg sublingual tablets |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2008-07-29
- Last updated
- 2023-03-20
- Results posted
- 2011-05-10
Source: ClinicalTrials.gov record NCT00723697. Inclusion in this directory is not an endorsement.