Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
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|ClinicalTrials.gov Identifier: NCT00638456|
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Drug: Budesonide plus Prevacid Drug: placebo plus Prevacid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Active Comparator: 1
oral viscous budesonide plus Prevacid
Drug: Budesonide plus Prevacid
Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Placebo Comparator: 2
placebo plus Prevacid
Drug: placebo plus Prevacid
Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
- Number of Participants With Improvement of Espohageal Eosinophilia [ Time Frame: 3 Months ]Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
- Upper Gastrointestinal Endoscopy Score [ Time Frame: Baseline and 3 Months ]
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.
- Symptom Score [ Time Frame: Baseline and 3 Months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638456
|United States, California|
|Rady Children's Hospital, San Diego|
|San Diego, California, United States, 92123|
|Principal Investigator:||Ranjan Dohil, MD||UCSD|