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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016692-29 | EudraCT Number |
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The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose budesonide tablet | Experimental |
| |
| High dose budesonide tablet | Experimental |
| |
| High dose budesonide suspension | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose budesonide tablet | Drug | 1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of histological remission | 2 weeks (LOCF) | |
| Change in the mean numbers of eos | 2 weeks (LOCF) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean numbers of eos | 2 weeks (LOCF) |
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Major Inclusion Criteria:
(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)
- Active symptomatic and histological EoE at baseline
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Mueller, PhD | Dr. Falk Pharma GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Digestive Diseases Eppendorf | Hamburg | 20249 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25792708 | Result | Miehlke S, Hruz P, Vieth M, Bussmann C, von Arnim U, Bajbouj M, Schlag C, Madisch A, Fibbe C, Wittenburg H, Allescher HD, Reinshagen M, Schubert S, Tack J, Muller M, Krummenerl P, Arts J, Mueller R, Dilger K, Greinwald R, Straumann A. A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis. Gut. 2016 Mar;65(3):390-9. doi: 10.1136/gutjnl-2014-308815. Epub 2015 Mar 19. |
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| high dose budesonide tablet | Drug | 2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily |
|
|
| high dose budesonide suspension | Drug | placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily |
|
|
| Placebo | Drug | placebo tablet twice daily AND 5ml placebo suspension twice daily |
|
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| C462501 | DNER protein, human |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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