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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: Completed Phase 2 study of Eosinophilic Esophagitis, sponsored by Ception Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.
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
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00538434 record still lists
NCT00538434 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 859-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (74% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Eosinophilic Esophagitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00538434's enrollment target sits among peer trials
227 14th of 44 higher than 31 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis 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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