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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: Nexium 20mg; Drug: Nexium 10mg

Detailed Description

Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age

Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5000
    • Research Site
  • Córdoba, Argentina, X5016KEH
    • Research Site
  • Paraná, Argentina, 3100
    • Research Site
  • Rosario, Argentina, S2000DEJ
    • Research Site
• Australia
  • Clayton, Australia, 3168
    • Research Site
• Belgium
  • Namur, Belgium, 5101
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Thessaloniki, Greece, 54642
    • Research Site
  • Thessaloniki, Greece, 56249
    • Research Site
• Italy
  • Messina, Italy, 98125
    • Research Site
  • Naples, Italy, 80138
    • Research Site
  • Naples, Italy, 80131
    • Research Site
  • Roma, Italy, 00161
    • Research Site
  • Roma, Italy, 00137
    • Research Site
• Lithuania
  • Vilnius, Lithuania, LT-08406
    • Research Site
• Portugal
  • Braga, Portugal, 4710
    • Research Site
  • Coimbra, Portugal, 3000-602
    • Research Site
  • Lisbon, Portugal, 1998-018
    • Research Site
  • Lisbon, Portugal, 1500-650
    • Research Site
  • Lisbon, Portugal, 1169-045
    • Research Site
  • Porto, Portugal, 4099-001
    • Research Site
  • Porto, Portugal, 4200-319
    • Research Site
  • Viana do Castelo, Portugal, 4901-858
    • Research Site
• Spain
  • Badalona, Spain, 08916
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Seville, Spain, 41009
    • Research Site
  • Seville, Spain, 41013
    • Research Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Research Site
  • California
    • Sacramento, California, United States, 95817
      • Research Site
  • Florida
    • Miami, Florida, United States, 33155
      • Research Site
    • Miami, Florida, United States, 33122
      • Research Site
    • Orlando, Florida, United States, 32806
      • Research Site
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Research Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Research Site
  • New York
    • The Bronx, New York, United States, 10468
      • Research Site
  • Ohio
    • Akron, Ohio, United States, 44308
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Hanoi, Vietnam, 10000
    • Research Site
  • Hochiminh, Vietnam, 700000
    • Research Site
  • Hà Nội, Vietnam, 100000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nexium - high dose; Arm 1 (High dose = Healing dose)	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.
Active Comparator: Nexium - Low dose; Arm 2 (Low dose = ½ healing dose)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence / absence of Erosive Esophagitis	Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase	Week 24 (end of 16-week maintenance phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of Erosive Esophagitis	Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase	Week 8 (end of healing phase)
Percentage of days without rescue medication	The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase	Week 8 (end of healing phase) and Week 16 (end of maintenance phase)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Laboratory Corporation of America; Medidata Solutions; IQVIA RDS Inc.; Calyx; Thermo Fisher Scientific, Inc; Quipment Inc.; Little Journey Ltd.; CISCRP

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 19, 2026

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: GERD; Endoscopy; EGD; Maintenance; Gastroesophageal Reflux Disease; Healing; Esophagogastroduodenoscopy; Erosive Esophagitis; GERD in children
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole; Esomeprazole
• Other Study ID Numbers: D9612C09998; 2020-002515-21 (EudraCT Number); 2023-505454-18-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No