Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/3/2018 |
| Start Date: | February 2016 |
| End Date: | September 19, 2018 |
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis
The purpose of this trial is 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 will be 6 months.
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 will be 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
We found this trial at
19
sites
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