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

Running, not enrolling · Phase 3

Conditions studied: Erosive Esophagitis

In brief

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.

Key facts

Study ID: NCT05267613
Run by: AstraZeneca
People needed: 53
Starts: 2022-07-01
Expected to finish: 2026-08-19
Last updated by the study team: 2026-07-27

Who can join

Age: 1 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must be 1 to 11 years of age
Patients must have a clinical 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 study intervention.
Patient's guardian must be capable of giving signed informed consent

You may not qualify if…

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

Where it is running

Research Site — Mobile, Alabama, United States
Research Site — Sacramento, California, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Carmel, Indiana, United States
Research Site — Shreveport, Louisiana, United States
Research Site — The Bronx, New York, United States
Research Site — Akron, Ohio, United States
Research Site — Cleveland, Ohio, United States
Research Site — Milwaukee, Wisconsin, United States
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

Full record on ClinicalTrials.gov

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