Phase 3/Safety & Efficacy of Esomeprazole in Infants
Public ClinicalTrials.gov record NCT00468559. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive
Study identification
- NCT ID
- NCT00468559
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AstraZeneca
- Industry
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Interventions
- Open Label Run In Esomeprazole Drug
- Double Blind Esomeprazole Drug
- Double Blind Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Month to 11 Months
- 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
- Mar 31, 2007
- Primary completion
- May 31, 2008
- Completion
- May 31, 2008
- Last update posted
- Jun 1, 2014
2007 – 2008
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Phoenix | Arizona | — | — |
| Research Site | Atlanta | Georgia | — | — |
| Research Site | Park Ridge | Illinois | — | — |
| Research Site | Louisville | Kentucky | — | — |
| Research Site | Marrero | Louisiana | — | — |
| Research Site | Newton | Massachusetts | — | — |
| Research Site | Southfield | Michigan | — | — |
| Research Site | Las Vegas | Nevada | — | — |
| Research Site | Brooklyn | New York | — | — |
| Research Site | New York | New York | — | — |
| Research Site | Akron | Ohio | — | — |
| Research Site | Dayton | Ohio | — | — |
| Research Site | Chattanooga | Tennessee | — | — |
| Research Site | Roanoke | Virginia | — | — |
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 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00468559, 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 Jun 1, 2014 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00468559 live on ClinicalTrials.gov.