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NCT00132496 · ClinicalTrials.gov registry record · Phase 2

Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole

A Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
111
Enrollment target
20
Study locations

NCT00132496 is a Phase 2 study of Gastroesophageal Reflux Disease that has completed, run by Eisai. The registered enrollment target is 111 participants, below the 343-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00132496, a Phase 2 study of Gastroesophageal Reflux Disease, has completed, sponsored by Eisai.

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

Study Summary

The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.

Conditions Studied

Gastroesophageal Reflux Disease

Interventions

  • DRUG rabeprazole sodium

Study Locations (20)

Ohio

  • Pediatric Associates of Mount Carmel, Inc. - Cincinnati
  • Pediatric Associates of Mt. Carmel - Cincinnati
  • University of Pediatrics - Mason
  • Center for Children's Digestive Health - Youngstown
  • Pharmacotherapy Research Associates - Zanesville

Florida

  • Nova Southeastern University - Fort Lauderdale
  • Babies and Beyond Peds - New Port Richey

Michigan

  • Professional Clinical Research - Cadillac
  • Community Pediatric Associates - Kalamazoo

New York

  • Children's Hospital of Buffalo - Digestive Disease And Nutrition Center - Buffalo
  • Winthrop University Hospital - Mineola

Tennessee

  • Focus Research Group - Hendersonville
  • ProMed Healthcare - Johnson City

Colorado

  • Longmont Medical Research Network - Longmont

Georgia

  • Dr. Patricia Barrington, Dr. B. Abraham, PC - Snellville

Illinois

  • Multi-specialty Clinical Research - Hoffman Estates

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2005-08
Est. Completion 2006-07
Phase Phase 2

Sponsor

Eisai

287 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00132496

The ClinicalTrials.gov registry entry for NCT00132496 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 343-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (68% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 1 intervention - of which rabeprazole sodium is the first listed.

NCT00132496 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Ohio, Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT00132496 about?

NCT00132496 is a clinical study titled "Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole". The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GER...

What is the current status of trial NCT00132496?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2005-08. Estimated completion is 2006-07.

What conditions does trial NCT00132496 study?

This clinical trial studies the following conditions: Gastroesophageal Reflux Disease.

What interventions are being tested in trial NCT00132496?

The interventions under investigation include: rabeprazole sodium (DRUG).

Who is sponsoring clinical trial NCT00132496?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00132496 being conducted?

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

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

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.