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COMPLETED Phase 2

The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

NCT00728481 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Esomeprazole
  • DRUG Budesonide

Study Locations (1)

Minnesota

  • Mayo Clinic — Rochester

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2008-05
Est. Completion 2010-12
Phase Phase 2

Sponsor

Mayo Clinic

3,246 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00728481

The ClinicalTrials.gov registry entry for NCT00728481 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00728481 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00728481?

The interventions under investigation include: Esomeprazole (DRUG), Budesonide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00728481?

This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial