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| Name | Class |
|---|---|
| Meritage Pharma, Inc. | INDUSTRY |
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This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | oral viscous budesonide plus Prevacid |
|
| 2 | Placebo Comparator | placebo plus Prevacid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide plus Prevacid | Drug | Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvement of Espohageal Eosinophilia | Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Gastrointestinal Endoscopy Score | Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ranjan Dohil, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital, San Diego | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20457157 | Derived | Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Viscous Budesonide Plus Prevacid | Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. |
| FG001 | Placebo Plus Prevacid | placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Viscous Budesonide Plus Prevacid | Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. |
| BG001 | Placebo Plus Prevacid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Improvement of Espohageal Eosinophilia | Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment. | 6 subjects withdrew from the oral viscous budesonide plus Prevacid group and 2 withdrew from the placebo plus Prevacid group, and so they were not included in the data analsyis. | Posted | Count of Participants | Participants | 3 Months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Viscous Budesonide Plus Prevacid | Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ranjan Dohil | Univeristy of California, San Diego | (858) 966-4003 | rdohil@ucsd.edu |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| placebo plus Prevacid | Drug | Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months. |
|
| Baseline and 3 Months |
| Symptom Score | Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms. | Baseline and 3 Months |
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Upper Gastrointestinal Endoscopy Score | Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease. | Posted | Mean | Full Range | units on a scale | Baseline and 3 Months |
|
|
|
| Secondary | Symptom Score | Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms. | Posted | Mean | Full Range | units on a scale | Baseline and 3 Months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 3 |
| 21 |
| EG001 | Placebo Plus Prevacid | placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months. | 0 | 11 | 0 | 11 | 5 | 11 |
| Oral Candida | Gastrointestinal disorders |
|
| Trasient headache | Nervous system disorders |
|
| Worsening Eczema | General disorders |
|
| Chest Infection | Infections and infestations |
|
| Mild Abdominal Pain | Gastrointestinal disorders |
|
| transient diarrehea | Gastrointestinal disorders |
|
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| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |