Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Status:	Completed
Conditions:	Colitis, Colitis, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	4/3/2019
Start Date:	October 2015
End Date:	April 3, 2018

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

The purpose of this trial is to investigate the efficacy of mesalamine for the induction of
clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will
receive 4 g extended release granules (sachet) once daily.

Inclusion Criteria:

- Male or female subjects aged 18 to 75 years

- Mild to moderate UC

Exclusion Criteria:

- Disease limited to proctitis <15 cm

- Short bowel syndrome

- Prior colon resection surgery

- History of severe/fulminant UC

- 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

We found this trial at

sites

Advanced Research Institute

Ogden, Utah 84405

from

Ogden, UT