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COMPLETED Phase 2

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

NCT00132496 · View on ClinicalTrials.gov ↗

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.

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

71 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. 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 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 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 Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 1 intervention — of which rabeprazole sodium 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: NCT00132496 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Ohio, Florida, Michigan. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00132496?

The interventions under investigation include: rabeprazole sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00132496?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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