Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Active Ulcerative Colitis Clinical Trial

Official title:
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Status Completed

Clinical Trial Summary

To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients with active ulcerative colitis (UC) treated for 8 weeks.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01257386
Study type	Interventional
Source	Tillotts Pharma AG
Contact
Status	Completed
Phase	Phase 3
Start date	November 2010
Completion date	March 2013

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00616434` - A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis	Phase 2
Completed	`NCT02748590` - Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)	N/A
Completed	`NCT01745770` - TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)	Phase 3
Completed	`NCT03235752` - Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis	Phase 2
Recruiting	`NCT05739864` - Superdonor FMT in Patients With Ulcerative Colitis	Phase 1/Phase 2