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.

AstraZeneca1 site in 1 country140 target enrollmentFebruary 2004

ConditionsGastroesophageal Reflux Disease (GERD)

DrugsEsomeprazole (Nexium)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Gastroesophageal Reflux Disease (GERD)
Sponsor: AstraZeneca
Enrollment: 140
Locations: 1
Primary Endpoint: To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

April 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

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.