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NCT00444145 · ClinicalTrials.gov registry record · Phase 4

Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?

A Phase 4 study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 4
Development phase
38
Enrollment target

NCT00444145: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.

NCT00444145 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00444145, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
38 participants
Enrollment target

Study Summary

The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy. The hypothesis is that the patients who have laryngeal signs and symptoms related to acid reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of response to therapy.

Primary Outcome

Dilation of inter cellular spaces (the space within the cell) is reported to be an early morphological (structure and form) marker in gastro-oesophageal reflux. Using electron microscopy, the distance between epithelial cells is quantified.

Interventions

  • DRUG Prevacid
  • PROCEDURE Esophageal and Laryngeal Biopsies

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2007-03
Est. Completion 2009-12
Phase Phase 4

What the finished NCT00444145 record still lists

NCT00444145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Prevacid is the first listed.

NCT00444145 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00444145 about?

NCT00444145 is a clinical study titled "Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?". The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy. The hypothesis is that the patients who have laryngeal signs and symptoms related to acid reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of response to the...

What is the current status of trial NCT00444145?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2007-03. Estimated completion is 2009-12.

What interventions are being tested in trial NCT00444145?

The interventions under investigation include: Prevacid (DRUG), Esophageal and Laryngeal Biopsies (PROCEDURE).

Who is sponsoring clinical trial NCT00444145?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00444145's enrollment target sits among peer trials

38 1476th of 2000 higher than 519 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00444145, the US trial registry maintained by the National Library of Medicine. NCT00444145 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.