Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

• Status: Completed
• Trial end date: 2018-09-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Mesalamine

Criteria

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