Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis

Study Overview
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Brief Summary
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The aim of this study is to determine if Nexium is safe and efficacious in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

Detailed Description
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Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.

Official Title
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A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: Nexium 20mg
* Drug: Nexium 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be 1 to 11 years of age Patients must have a history of GERD for at least 3 months before the start of study For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit. Patients must weigh ≥ 10 kg. Patients may be male or female. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of IMP treatment. Patient's guardian must be capable of giving signed informed consent Exclusion Criteria: Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar Significant clinical illness within 4 weeks prior to the start of treatment Any conditions that are predicted to require a surgery during the study period (from the day of informed consent to the day of the last scheduled visit) Previous total gastrectomy Anticipated need for concomitant therapy with PPIs (except for the IMPs), H2-receptor antagonists and other drugs outlined in EC#5 after enrollment in this study Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Judgment by the Investigator that the patient should not participate in the study if the patient or guardian is unlikely to comply with study procedures, restrictions, and requirements Previous screening, or enrollment and randomization in the present study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 11 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nexium - high dose<br>Arm 1 (High dose = Healing dose) | Drug: Nexium 20mg<br>* Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.<br>|
| Active Comparator: Nexium - Low dose<br>Arm 2 (Low dose = ½ healing dose) | Drug: Nexium 10mg<br>* Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence / absence of Erosive Esophagitis | Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase | Week 24 (end of 16-week maintenance phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of Erosive Esophagitis | Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase | Week 8 (end of healing phase) | 
| Percentage of days without rescue medication | The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase | Week 8 (end of healing phase) and Week 16 (end of maintenance phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erosive Esophagitis, Gastroesophageal Reflux Disease, Healing, Maintenance, Esophagogastroduodenoscopy, Endoscopy, EGD, GERD, GERD in children