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Completed Phase 1 Interventional

A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)

ClinicalTrials.gov ID: NCT00855361

Public ClinicalTrials.gov record NCT00855361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 8:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants With a Corrected Age of Less Than 44 Weeks With a Presumptive Diagnosis of GERD

Study identification

NCT ID
NCT00855361
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
69 participants

Conditions and interventions

Interventions

  • Rabeprazole sodium Drug

Drug

Eligibility (public fields only)

Age range
Up to 44 Weeks
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2009
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011
Last update posted
Apr 28, 2013

2009 – 2011

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Not listed Orange California
Not listed Washington D.C. District of Columbia
Not listed Augusta Georgia
Not listed Maywood Illinois
Not listed Louisville Kentucky
Not listed Shreveport Louisiana
Not listed Lansing Michigan
Not listed Omaha Nebraska
Not listed Brooklyn New York
Not listed Toledo Ohio

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00855361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 28, 2013 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00855361 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →