Trials / Completed
CompletedNCT00605033
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- Indivior Inc. · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
Summary
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 | Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days |
| DRUG | Subutex, Buprenorphine Hydrochloride, SCH 28444 | Subutex sublingual tablet 4-24 mg, daily for 28 days |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2009-04-01
- Completion
- 2009-05-01
- First posted
- 2008-01-30
- Last updated
- 2016-10-21
- Results posted
- 2010-06-30
Source: ClinicalTrials.gov record NCT00605033. Inclusion in this directory is not an endorsement.