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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001912-31 | EudraCT Number |
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The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Budesonide granules 9 mg |
|
| B | Placebo Comparator | Placebo granules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide granules 9 mg | Drug | per day |
| |
| Placebo granules |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical remission | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical remission | 2 weeks | |
| Rate of clinical remission | 6 weeks | |
| Time to remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Münch, MD | University Hospital of Linköping, Dept. of Gastroenterology and Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Digestive Diseases | Hamburg | 20249 | Germany | |||
| University Hospital of Linköping, Dept. of Gastroenterology and Hepatology |
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| Drug |
per day |
|
| 8 weeks |
| Number of formed/soft/watery stools per week | 8 weeks |
| Number of days with abdominal pain | 8 weeks |
| Number of days with urgency | 8 weeks |
| Rate of histological remission | 8 weeks |
| Physician's global assessment at final visit | 8 weeks |
| Quality of life | 8 weeks |
| Linköping |
| 58185 |
| Sweden |