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

Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)

Intervention: Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: A Phase III, Multicentre, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Primary outcome:

To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients

12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G

Secondary outcome:

To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age

- Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.

- Assessment of changes from baseline in Physician Global Assessment.

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Research Site, Tours, France

Research Site, Lille, France

Research Site, Paris, France

Research Site, Roma, Italy

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, Genova, GE, Italy

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, St. Paul, Minnesota, United States

Research Site, Jackson, Mississippi, United States

Research Site, Binghamton, New York, United States

Research Site, Bronx, 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, Mount Pearl, Newfoundland and Labrador, Canada

Research Site, Winston Salem, North Carolina, United States

Research Site, Halifax, Nova Scotia, Canada

Research Site, Cleveland, Ohio, United States

Research Site, Dayton, Ohio, United States

Research Site, Hamilton, Ontario, Canada

Research Site, Scarborough, Ontario, Canada

Research Site, Sudbury, Ontario, Canada

Research Site, Oakville, Ontario, Canada

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Parkdale, Prince Edward Island, Canada

Research Site, Chattanooga, Tennessee, United States

Research Site, Burlington, Vermont, United States

Research Site, Norfolk, Virginia, United States

Starting date: February 2004
Last updated: October 18, 2005