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NCT00728481 · ClinicalTrials.gov registry record · Phase 2
The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis
A Phase 2 study of Eosinophilic Esophagitis and Gastroesophageal Reflux Disease, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT00728481: Completed Phase 2 study of Eosinophilic Esophagitis and Gastroesophageal Reflux Disease, sponsored by Mayo Clinic.
NCT00728481 is a Phase 2 study of Eosinophilic Esophagitis and Gastroesophageal Reflux Disease that has completed, run by Mayo Clinic. The registered enrollment target is 51 participants, below the 863-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00728481, a Phase 2 study of Eosinophilic Esophagitis and Gastroesophageal Reflux Disease, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD). This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from taking the medication Nexium or a steroid called Pulmicort. The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus as a predictor of endoscopic, histological and symptomatic response in patients with EE.
Primary Outcome
Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.
Conditions Studied
Interventions
- DRUG Esomeprazole
- DRUG Budesonide
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT00728481 record still lists
NCT00728481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 863-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (94% lower).
The record links to 4 conditions, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 2 interventions - of which Esomeprazole is the first listed.
NCT00728481 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00728481 about?
NCT00728481 is a clinical study titled "The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis". The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD). This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would...
What is the current status of trial NCT00728481?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2008-05. Estimated completion is 2010-12.
What conditions does trial NCT00728481 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis, Gastroesophageal Reflux Disease, GERD, EE.
What interventions are being tested in trial NCT00728481?
The interventions under investigation include: Esomeprazole (DRUG), Budesonide (DRUG).
Who is sponsoring clinical trial NCT00728481?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00728481 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00728481's enrollment target sits among peer trials
51 29th of 44 higher than 16 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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