Phase 3/Safety & Efficacy of Esomeprazole in Infants

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.

Key facts

Study ID

NCT00468559

Run by

AstraZeneca

People needed

98

Starts

2007-04-01

Expected to finish

2008-06-01

Last updated by the study team

2014-06-02

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
• patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams

You may not qualify if…

• patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
• patients with a history of acute life-threatening event

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Park Ridge, Illinois, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Marrero, Louisiana, United States
• Research Site — Newton, Massachusetts, United States
• Research Site — Southfield, Michigan, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Brooklyn, New York, United States
• Research Site — New York, New York, United States
• Research Site — Akron, Ohio, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Roanoke, Virginia, United States
• Research Site — Lille, France
• Research Site — Paris, France
• Research Site — Bochum, Germany
• Research Site — Greifswald, Germany
• Research Site — Nurberg, Germany
• Research Site — Potsdam, Germany
• Research Site — Wuppertal, Germany
• Research Site — Bialystok, Poland
• Research Site — Krakow, Poland
• Research Site — Warsaw, Poland
• Research Site — Wroclaw, Poland

Full record on ClinicalTrials.gov

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