Nexium 20mg: 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.
Nexium 10mg: 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.
Study summary
The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.
Eligibility
Sex
ALL
Min age
1 Year
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patient must be 1 to 11 years of age
2. Patients must have a clinical history of GERD for at least 3 months before the start of study
3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
4. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
5. Patients must weigh ≥ 10 kg.
6. Patients may be male or female.
7. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
8. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of study intervention.
9. Patient's guardian must be capable of giving signed informed consent
Exclusion Criteria:
1. Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
2. Significant clinical illness within 4 weeks prior to the start of treatment
3. 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)
4. Previous total gastrectomy
5. 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
6. Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
8. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
9. 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
10. Previous screening, or enrollment and randomization in the present study
Primary outcome measure(s)
Presence / absence of Erosive Esophagitis — Week 24 (end of 16-week maintenance phase) Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
Trial sites (41)
Facility
City
Region
Status
Research Site
Mobile
Alabama
Research Site
Sacramento
California
Research Site
Miami
Florida
Research Site
Miami
Florida
Research Site
Orlando
Florida
Research Site
Carmel
Indiana
Research Site
Shreveport
Louisiana
Research Site
The Bronx
New York
Research Site
Akron
Ohio
Research Site
Cleveland
Ohio
Research Site
Milwaukee
Wisconsin
Research Site
Córdoba
Argentina
Research Site
Córdoba
Argentina
Research Site
Paraná
Argentina
Research Site
Rosario
Argentina
Research Site
Clayton
Australia
Research Site
Namur
Belgium
Research Site
Athens
Greece
Research Site
Thessaloniki
Greece
Research Site
Thessaloniki
Greece
Research Site
Messina
Italy
Research Site
Naples
Italy
Research Site
Naples
Italy
Research Site
Roma
Italy
Research Site
Roma
Italy
Research Site
Vilnius
Lithuania
Research Site
Coimbra
Portugal
Research Site
Lisbon
Portugal
Research Site
Lisbon
Portugal
Research Site
Lisbon
Portugal
Research Site
Porto
Portugal
Research Site
Porto
Portugal
Research Site
Viana do Castelo
Portugal
Research Site
Badalona
Spain
Research Site
Santiago de Compostela
Spain
Research Site
Seville
Spain
Research Site
Seville
Spain
Research Site
Hanoi
Vietnam
Research Site
Hanoi
Vietnam
Research Site
Hà Nội
Vietnam
+ 1 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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