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Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
Sponsor: AstraZeneca
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.
Official title: 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
Key Details
Gender
All
Age Range
1 Year - 11 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-07-01
Completion Date
2027-09-06
Last Updated
2025-11-06
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (55)
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Mobile, Alabama, United States
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Fontana, California, United States
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Orange, California, United States
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Sacramento, California, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Downers Grove, Illinois, United States
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Carmel, Indiana, United States
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Springfield, Massachusetts, United States
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The Bronx, New York, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Milwaukee, Wisconsin, United States
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Córdoba, Argentina
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Córdoba, Argentina
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Paraná, Argentina
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Rosario, Argentina
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Clayton, Australia
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North Adelaide, Australia
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Brussels, Belgium
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Namur, Belgium
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Athens, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Messina, Italy
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Naples, Italy
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Naples, Italy
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Roma, Italy
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Roma, Italy
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Kaunas, Lithuania
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Vilnius, Lithuania
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Porto, Portugal
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Viana do Castelo, Portugal
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Novosibirsk, Russia
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Pyatigorsk, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Tomsk, Russia
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Badalona, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Seville, Spain
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Hanoi, Vietnam
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Hanoi, Vietnam
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Hà Nội, Vietnam
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Hochiminh, Vietnam