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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: Completed Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Eisai.
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 351-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2005-08 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
What the finished NCT00132496 record still lists
NCT00132496 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 351-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (68% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux Disease
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 NCT00132496's enrollment target sits among peer trials
111 12th of 25 higher than 14 of 25 other Gastroesophageal Reflux Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease 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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