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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Drug: Esomeprazole (Nexium)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole (Nexium)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |