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Clinical Trials in the USA / NCT05267613
Active, not recruiting Phase 3

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

NCT05267613 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-07-01
Last updated
2026-07-27

Condition(s) studied

Erosive Esophagitis

Investigational drug(s) / intervention(s)

Nexium 20mgNexium 10mg

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)

Trial sites (41)

FacilityCityRegionStatus
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.

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT05267613 on ClinicalTrials.gov ↗ ← All trials in the USA