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

Ferring

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Placebo Enema

Drug: Mesalazine Enema

Study type

Interventional

Funder types

Industry

Identifiers

NCT02368717

000101

Details and patient eligibility

About

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.

Enrollment

281 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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