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NCT00992589 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
344
Enrollment target

NCT00992589 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 344 participants.

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The verdict

NCT00992589, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
344 participants
Enrollment target

Study Summary

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

Interventions

  • DRUG Placebo
  • DRUG Rabeprazole sodium 5 mg
  • DRUG Rabeprazole sodium 10 mg

Trial Details

FieldValue
Enrollment Target 344 participants
Start Date 2009-11
Est. Completion 2011-11
Phase Phase 3

What the Registry Record Tells You About NCT00992589

The ClinicalTrials.gov registry entry for NCT00992589 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 344 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00992589 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00992589 about?

NCT00992589 is a clinical study titled "Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)". The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

What is the current status of trial NCT00992589?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 344 participants. The study started on 2009-11. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00992589?

The interventions under investigation include: Placebo (DRUG), Rabeprazole sodium 5 mg (DRUG), Rabeprazole sodium 10 mg (DRUG).

Who is sponsoring clinical trial NCT00992589?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

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.