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This will be a randomised, double blind, placebo controlled, parallel group evaluation of the effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC000459 | Experimental | OC000459 100mg twice daily |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC000459 | Drug | OC000459 100mg, twice daily, tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of OC000459 on eosinophil load of the esophageal tissue | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of OC000459 on clinical manifestations of EoE | 8 weeks | |
| Effect of OC000459 on endoscopic alterations | 8 weeks | |
| Effect of OC000459 on EoE related blood and tissue biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Straumann, Dr | Swiss EoE Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss EoE Research Group | Olten | CH-4600 | Switzerland |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C571151 | (5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid |
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| Drug |
Placebo tablets to match OC000459 tablets, twice daily |
|
| 8 weeks |
| Safety and tolerability of OC000459 in patients with active EoE | 8 weeks |
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |