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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesalazine | Experimental | Mesalazine Enema |
|
| Placebo | Placebo Comparator | Placebo Enema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalazine Enema | Drug |
|
| |
| Placebo Enema |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 6th hospital affiliated to Zhongshan University (there may be other sites in this country) | Guangzhou | China |
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| Drug |
|
Based on the Inflammatory Bowel Disease Questionnaire (IBDQ) |
| From baseline to week 4 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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