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Using Nexium to maintain healing in children with erosive esophagitis

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

PHASE3 · AstraZeneca · NCT05267613

This study is testing if different doses of Nexium can help keep children aged 1 to 11 with healed erosive esophagitis from getting worse again.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment100 (estimated)
Ages1 Year to 11 Years
SexAll
SponsorAstraZeneca (industry)
Locations53 sites (Fontana, California and 52 other locations)
Trial IDNCT05267613 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of two different doses of Nexium (esomeprazole) in maintaining the healing of erosive esophagitis in children aged 1 to 11 years. The trial involves a healing phase followed by a maintenance phase, where only children with confirmed healed erosive esophagitis will receive the medication. Safety assessments will include monitoring adverse events, laboratory tests, vital signs, and physical examinations throughout the study. The study is conducted in collaboration with the FDA to gather data on the use of Nexium in this pediatric population.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1 to 11 years who have a clinical history of gastroesophageal reflux disease and have confirmed erosive esophagitis.

Not a fit: Patients with other severe health conditions or diseases that could interfere with the study outcomes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective treatment option for maintaining healing in children with erosive esophagitis.

How similar studies have performed: Previous studies have shown positive outcomes with similar approaches in treating erosive esophagitis, but this specific use of Nexium in children is being further evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Fontana, California and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Erosive Esophagitis, Gastroesophageal Reflux Disease, Healing, Maintenance, Esophagogastroduodenoscopy, Endoscopy, EGD, GERD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.