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NCT00538434 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

A Phase 2 study of Eosinophilic Esophagitis, sponsored by Ception Therapeutics.

Completed
Registry status
Phase 2
Development phase
227
Enrollment target
20
Study locations

NCT00538434 is a Phase 2 study of Eosinophilic Esophagitis that has completed, run by Ception Therapeutics. The registered enrollment target is 227 participants, below the 859-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT00538434, a Phase 2 study of Eosinophilic Esophagitis, has completed, sponsored by Ception Therapeutics.

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

Study Summary

This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.

Conditions Studied

Eosinophilic Esophagitis

Interventions

  • OTHER Saline
  • BIOLOGICAL Reslizumab

Study Locations (20)

California

  • Kaiser Permanente Hospital- Pediatric Gastroenterology - Hayward
  • Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma - Orange
  • Pediatric Allergy/Immunology - Palo Alto
  • Children's Hospital of San Diego - San Diego

Colorado

  • Denver Childrens At Aurora, Colorado - Aurora
  • 1st Allergy and Clinical Research Center - Centennial

Illinois

  • University of Chicago - Chicago
  • Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition - Chicago

Alabama

  • The Children's Hospital of Alabama - Birmingham

Arizona

  • University of Arizona Dept. of Pediatrics - Tucson

Arkansas

  • Arkansas Children's Hospital/University of Arkansas for Medical Sciences - Little Rock

Delaware

  • Thomas Jefferson University Medical College - Wilmington

Georgia

  • Children's Center for Digestive Health Care - Atlanta

Trial Details

FieldValue
Enrollment Target 227 participants
Start Date 2008-03
Est. Completion 2009-10
Phase Phase 2

Sponsor

Ception Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00538434

The ClinicalTrials.gov registry entry for NCT00538434 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 859-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (74% lower). The listed sponsor is Ception Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.

NCT00538434 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Colorado, Illinois.

Frequently Asked Questions

What is clinical trial NCT00538434 about?

NCT00538434 is a clinical study titled "Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years". This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety...

What is the current status of trial NCT00538434?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2008-03. Estimated completion is 2009-10.

What conditions does trial NCT00538434 study?

This clinical trial studies the following conditions: Eosinophilic Esophagitis.

What interventions are being tested in trial NCT00538434?

The interventions under investigation include: Saline (OTHER), Reslizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00538434?

This trial is sponsored by Ception Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00538434 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.