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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Mesalazine Enema
* Drug: Placebo Enema


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesalazine<br>Mesalazine Enema | Drug: Mesalazine Enema<br> <br> * Other names: PENTASA® Enema;|
| Placebo Comparator: Placebo<br>Placebo Enema | Drug: Placebo Enema<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission after 4 weeks treatment | Defined as a total Mayo score ≤2 points, with no subscore >1 point | At week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response after 4 weeks treatment | Defined as a decrease from baseline in total Mayo score ≥3 points and ≥ 30 percent, with an accompanying decrease in the subscore for rectal bleeding ≥ 1 point or an absolute subscore for rectal bleeding of 0 or 1 point | At week 4 | 
| Change in Quality of Life | Based on the Inflammatory Bowel Disease Questionnaire (IBDQ) | From baseline to week 4 |