An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Col… (NCT02368717) | Clinical Trial Compass
CompletedPhase 3
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
China281 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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