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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000720-13 | EudraCT Number |
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This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.
This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose TSO | Experimental | Low dose suspension of TSO |
|
| Medium dose TSO | Experimental | Medium dose suspension of TSO |
|
| High dose TSO | Experimental | High dose suspension of TSO |
|
| Placebo | Placebo Comparator | Placebo solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose TSO | Drug | Low dose TSO suspension |
| |
| Medium dose TSO |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of > 100 points in CDAI | 12 weeks | |
| Adverse events | 12 weeks |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jürgen Schölmerich, Prof. | Klinikum der Johann Wolfgang Goethe-Universität | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt a.M. | Hesse | 60590 | Germany |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
Medium dose TSO suspension |
|
| High dose TSO | Drug | High dose TSO suspension |
|
| Placebo | Drug | Placebo solution |
|
| D007410 | Intestinal Diseases |