NCT00746447

Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)

Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 648 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis

Conditions

• Colitis, Ulcerative
• Recurrence

Interventions

Type	Name	Description
DRUG	mesalamine granules	3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
DRUG	mesalamine granules	1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
DRUG	mesalamine granules	0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-04-01
• Completion: 2008-03-01
• First posted: 2008-09-04
• Last updated: 2012-06-26

Locations

1 site across 1 country: Germany