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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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