Esomeprazole for Treatment of GERD in Pediatric Patients

Condition(s) targeted: Gastroesophageal Reflux Disease (GERD); Erosive Esophagitis; Non-Erosive Esophagitis

Intervention: Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.

To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.

Official title: A Phase III, Multicentre, Randomized, Double-Blind Parallel-Group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study

Primary outcome:

The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.

The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.

Secondary outcome:

The secondary objective of the study is to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric patients 1 to 11 years of age, inclusive.

The secondary objectives include:

- Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian.

- Assessment of changes from baseline in Physician's Global Assessment

- Assessment of endoscopic healing of erosive esophagitis

Minimum age: 1 Year. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients' parents/guardians must provide written informed consent prior to the

execution of any study-related procedures.

- Patients who are able to comprehend their involvement in a clinical study, including

risks and benefits, (typically ≥6 years of age) must have assent documented by study personnel prior to any study-related procedures.

- Patients must be diagnosed with endoscopically proven GERD by the investigator during

the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy.

Exclusion Criteria:

- Patients who have used a proton pump inhibitor within 14 days prior to randomization,

including over-the-counter omeprazole.

- Patients who have used any prescription or over-the-counter (OTC) treatment (other

than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.

- Patients with a known hypersensitivity, allergy, or intolerance to any component of

esomeprazole or omeprazole.

Research Site, Brussels, Belgium

Research Site, Brussels (Jette), Belgium

Research Site, Brussels (Laeken), Belgium

Research Site, Brussels (Woluwé-St-Lambert), Belgium

Research Site, Leuven, Belgium

Research Site, TOURS, France

Research Site, Lille, France

Research Site, Paris, France

Research Site, Napoli, Italy

Research Site, Mobile, Alabama, United States

Research Site, Phoenix, Arizona, United States

Research Site, Wilmington, Delaware, United States

Research Site, Orlando, Florida, United States

Research Site, GENOVA, GE, Italy

Research Site, Chicago, Illinois, United States

Research Site, Park Ridge, Illinois, United States

Research Site, Boston, Massachusetts, United States

Research Site, Detroit, Michigan, United States

Research Site, Troy, Michigan, United States

Research Site, Jackson, Mississippi, United States

Research Site, St. Louis, Missouri, United States

Research Site, Omaha, Nebraska, United States

Research Site, Morristown, New Jersey, United States

Research Site, Brooklyn, New York, United States

Research Site, Buffalo, New York, United States

Research Site, West Islip, New York, United States

Research Site, Columbus, Ohio, United States

Research Site, Parma, PR, Italy

Research Site, Hershey, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, ROMA, RM, Italy

Research Site, Chattanooga, Tennessee, United States

Research Site, Dallas, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Burlington, Vermont, United States

Research Site, Norfolk, Virginia, United States

Starting date: October 2004
Ending date: October 2007
Last updated: November 19, 2007