Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.

Key facts

Study ID

NCT00241501

Run by

AstraZeneca

People needed

140

Starts

2004-02-01

Expected to finish

2005-04-01

Last updated by the study team

2010-11-19

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures.
• Patients must be male or female between the age of 12 and 17 years, inclusive.
• Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing.

You may not qualify if…

• Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®.
• Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth.
• Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Wilmington, Delaware, United States
• Research Site — Orlando, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Park Ridge, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Waltham, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Plymouth, Minnesota, United States
• Research Site — Saint Paul, Minnesota, United States
• Research Site — Jackson, Mississippi, United States
• Research Site — Binghamton, New York, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Buffalo, New York, United States
• Research Site — Johnson City, New York, United States
• Research Site — New Hyde Park, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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