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RECRUITING
NCT05267613
PHASE3

Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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