NCT02368717CompletedPhase 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 281
- Locations
- 1
- Primary Endpoint
- Clinical remission after 4 weeks treatment
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Mesalazine Enema
Intervention: Mesalazine Enema (Drug)
Placebo
Placebo Comparator
Placebo Enema
Intervention: Placebo Enema (Drug)
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)
Investigators
Study Sites (1)
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