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NCT00358449 · ClinicalTrials.gov registry record · Phase 2

Intravenous Mepolizumab In Children With Eosinophilic Esophagitis

A Phase 2 study of Oesophagitis, Eosinophilic, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target
20
Study locations

NCT00358449: Completed Phase 2 study of Oesophagitis, Eosinophilic, sponsored by GlaxoSmithKline.

NCT00358449 is a Phase 2 study of Oesophagitis, Eosinophilic that has completed, run by GlaxoSmithKline. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00358449, a Phase 2 study of Oesophagitis, Eosinophilic, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.

Primary Outcome

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE's were considered to have a

Conditions Studied

Interventions

  • DRUG mepolizumab

Study Locations (20)

Indiana

  • GSK Investigational Site - Evansville
  • GSK Investigational Site - Indianapolis

Michigan

  • GSK Investigational Site - Southfield
  • GSK Investigational Site - Troy

Missouri

  • GSK Investigational Site - Kansas City
  • GSK Investigational Site - St Louis

Texas

  • GSK Investigational Site - Dallas
  • GSK Investigational Site - Dallas

Alabama

  • GSK Investigational Site - Birmingham

California

  • GSK Investigational Site - San Diego

Florida

  • GSK Investigational Site - Tampa

Georgia

  • GSK Investigational Site - Atlanta

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2006-09-11
Est. Completion 2008-11-25
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT00358449 record still lists

NCT00358449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).

The record links to 1 condition, with Oesophagitis, Eosinophilic appearing as the primary indexed condition, and to 1 intervention - of which mepolizumab is the first listed.

NCT00358449 names 20 study sites across 16 states, led by Indiana, Michigan, Missouri.

Frequently Asked Questions

What is clinical trial NCT00358449 about?

NCT00358449 is a clinical study titled "Intravenous Mepolizumab In Children With Eosinophilic Esophagitis". This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.

What is the current status of trial NCT00358449?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2006-09-11. Estimated completion is 2008-11-25.

What conditions does trial NCT00358449 study?

This clinical trial studies the following conditions: Oesophagitis, Eosinophilic.

What interventions are being tested in trial NCT00358449?

The interventions under investigation include: mepolizumab (DRUG).

Who is sponsoring clinical trial NCT00358449?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00358449 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00358449's enrollment target sits among peer trials

84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00358449, the US trial registry maintained by the National Library of Medicine. NCT00358449 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.