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NCT00961233 · ClinicalTrials.gov registry record · NA

Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT00961233: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT00961233 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00961233, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.

Primary Outcome

Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment

Interventions

  • DRUG inhaled/swallowed budesonide
  • DRUG viscous/swallowed budesonide

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2009-10
Est. Completion 2011-11
Phase NA

What the finished NCT00961233 record still lists

NCT00961233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which inhaled/swallowed budesonide is the first listed.

NCT00961233 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00961233 about?

NCT00961233 is a clinical study titled "Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)". The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determin...

What is the current status of trial NCT00961233?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2009-10. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00961233?

The interventions under investigation include: inhaled/swallowed budesonide (DRUG), viscous/swallowed budesonide (DRUG).

Who is sponsoring clinical trial NCT00961233?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00961233's enrollment target sits among peer trials

25 1712th of 2000 higher than 265 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT00961233, the US trial registry maintained by the National Library of Medicine. NCT00961233 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.