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Clinical trial

A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks

NCT00603733 is registered in ClinicalTrials.gov with Ferring Pharmaceuticals as lead sponsor.

NCT NCT00603733
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Registry record

As filed in ClinicalTrials.gov.

Title
A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks
Lead sponsor
Ferring Pharmaceuticals
Phase
Phase 3
Overall status
Completed
Start date
October 31, 2007
Completion date
May 31, 2011
Enrollment
288 (actual)
Sites
27

Conditions

As the registry lists them; a condition with its own page is linked.

active ulcerative colitis, remission of ulcerative colitis