NCT02522767.

Study name	A randomized, double‐blind, placebo‐controlled, multicenter study investigating the efficacy and safety of mesalamine 4 g extended release granules (sachet) for the induction of clinical and endoscopic remission in active, mild to moderate ulcerative Colitis
Methods	Participants were randomized to 1 of 2 groups: Mesalamine (4g extended release granules) Placebo comparator
Participants	Inclusion criteria: Men or women aged 18 to 75 years Mild to moderate ulcerative colitis Exclusion criteria: Disease limited to proctitis < 15 cm Short bowel syndrome Prior colon resection surgery History of severe/fulminant ulcerative colitis Evidence of other forms of inflammatory bowel disease Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]) Intolerant or allergic to aspirin or salicylate derivatives Use of rectal formulations (5‐aminosalicylic acid [5‐ASA], steroids) within ≤ 7 days Women who are pregnant or nursing History or known malignancy History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial
Interventions	4g extended release granules of Mesalamine and placebo
Outcomes	Primary outcomes: Proportion of participants with remission (time frame: at week 8); defined by the Clinical and Endoscopic Response Score based on a modified 9‐point Mayo score Secondary outcomes: Proportion of participants with remission in the primary endpoint and the Physician's Global Assessment (PGA) (time frame: at week 8) Time to cessation of rectal bleeding (time frame: up to week 8) Severity of adverse events (time frame: up to week 16) Incidence of adverse events (time frame: up to week 16)
Starting date	October 2015
Contact information	Clinical Development Support: DK0-Disclosure@ferring.com
Notes	This study is currently recruiting participants The estimated completion date is 28 February 2018