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COMPLETED Phase 2

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

NCT00538434 · View on ClinicalTrials.gov ↗

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

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

1 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. 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 227 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ception Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT00538434 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Colorado, Illinois. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00538434?

The interventions under investigation include: Saline (OTHER), Reslizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00538434?

This trial is sponsored by Ception Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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