Trials / Completed
CompletedNCT00347048
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 16 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tacrolimus | oral |
| DRUG | Placebo | oral |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2006-07-04
- Last updated
- 2014-08-26
Locations
6 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00347048. Inclusion in this directory is not an endorsement.