NCT06176560

Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.

A Randomised, Double-blind, Double-dummy, Multicentre, Phase III, Non Inferiority Trial of an Oral Mesalazine Formulation in Patients With Active Mild to Moderate Ulcerative Colitis for the Induction of Remission.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Mesalazine	Oral Formulation

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-12-19
• Last updated: 2023-12-19