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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

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Disease Information

Descriptive Information
Brief Title † 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
Official Title † A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets
Brief 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.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Clinical remission after 4 weeks treatment
Secondary Outcome Measure † Clinical response after 4 weeks treatment
Condition † Ulcerative Colitis
Intervention † DrugMesalazine Enema
Study Arms / Comparison Groups Mesalazine Mesalazine Enema Placebo Placebo Enema
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 279
Start Date † March 2015
Completion Date July 2017
Primary Completion Date January 5, 2017
Eligibility 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
Gender All
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT02368717
Organization ID 000101
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Ferring Pharmaceuticals
Collaborators ††
Investigators † Study Director: Clinical Development Support, Ferring Pharmaceuticals
Information Provided By
Verification Date April 2017
First Received Date † February 16, 2015
Last Updated Date April 18, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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