Trials / Completed
CompletedNCT01257399
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 251 (actual)
- Sponsor
- Tillotts Pharma AG · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Asacol® | 400 mg tablets |
| DRUG | Mesalazine | 400mg tablets |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2013-01-01
- Completion
- 2013-03-01
- First posted
- 2010-12-09
- Last updated
- 2013-04-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01257399. Inclusion in this directory is not an endorsement.