NCT02368717
Completed
Phase 3
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
ConditionsUlcerative Colitis
Overview
- Phase
- Phase 3
- Intervention
- Mesalazine Enema
- Conditions
- Ulcerative Colitis
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 281
- Locations
- 1
- Primary Endpoint
- Clinical remission after 4 weeks treatment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
Mesalazine
Mesalazine Enema
Intervention: Mesalazine Enema
Placebo
Placebo Enema
Intervention: Placebo Enema
Outcomes
Primary Outcomes
Clinical remission after 4 weeks treatment
Time Frame: At week 4
Defined as a total Mayo score ≤2 points, with no subscore \>1 point
Secondary Outcomes
- Change in Quality of Life(From baseline to week 4)
- Clinical response after 4 weeks treatment(At week 4)
Study Sites (1)
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