An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

• Status: Completed
• Trial end date: 2017-07-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.

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

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Newly diagnosed or recurrent mild to moderate left-sided active ulcerative colitis

• Mayo score of at least 4 but not greater than 10 points and a score of ≥ 2 for colonoscopy

• Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy

• The patient is compliant with Patient Daily Diary by having adequately responded to the questions on ≥5 of the most recent full 7 days before the Randomization Visit

• Negative stool test at screening to rule out parasites and bacterial pathogens

Exclusion Criteria:

• Patients receiving > 2g/day of oral 5-aminosalicylic acid (5-ASA) products, or receiving topical rectal 5-ASA > 3g/week, within 7 days prior to screening

• Severe/fulminant ulcerative colitis or toxic dilatation of the colon

• Prior bowel resection surgery

• Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates

• Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease

• Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures