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This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Disease activity index score (DAI score) | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of DAI score ( Total & each item) | 2 Weeks | |
| Changes of clinical severity and symptom | 2 Weeks | |
| Endoscopic finding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | oral |
|
| 2 Weeks |
| Patients impression | 2 Weeks |
| Amount of steroid | 2 Weeks |
| Hokkaido Region |
| Japan |
| Kansai Region | Japan |
| Kanto Region | Japan |
| Kyushu Region | Japan |
| Shin'etsu Region | Japan |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |