Expired Study
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Wilmington, North Carolina


The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.


Inclusion Criteria: - Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission Exclusion Criteria: - Evidence of other forms of inflammatory bowel disease - Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]) - Disease limited to proctitis <15 cm - Short bowel syndrome - Prior colon resection surgery - History of severe/fulminant UC - 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 of 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



Primary Contact:

Study Director
Global Clinical Compliance
Ferring Pharmaceuticals

Backup Contact:


Location Contact:

Wilmington, North Carolina
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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