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
3 other identifiers
interventional
53
10 countries
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2022
Typical duration for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 19, 2026
April 22, 2026
April 1, 2026
4.1 years
January 31, 2022
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Presence/absence of Erosive Esophagitis
Week 8 (end of healing phase)
Percentage of days without rescue medication
Week 8 (end of healing phase) and Week 16 (end of maintenance phase)
Study Arms (2)
Nexium - high dose
ACTIVE COMPARATORArm 1 (High dose = Healing dose)
Nexium - Low dose
ACTIVE COMPARATORArm 2 (Low dose = ½ healing dose)
Interventions
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® (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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- IQVIA RDS Inc.collaborator
- Calyxcollaborator
- Laboratory Corporation of Americacollaborator
- Medidata Solutionscollaborator
- Thermo Fisher Scientific, Inccollaborator
- CISCRPcollaborator
- Quipment Inc.collaborator
- Little Journey Ltd.collaborator
Study Sites (42)
Research Site
Mobile, Alabama, 36604, United States
Research Site
Sacramento, California, 95817, United States
Research Site
Miami, Florida, 33122, United States
Research Site
Miami, Florida, 33155, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
Carmel, Indiana, 46290, United States
Research Site
Shreveport, Louisiana, 71103, United States
Research Site
The Bronx, New York, 10468, United States
Research Site
Akron, Ohio, 44308, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Milwaukee, Wisconsin, 53226, United States
Research Site
Córdoba, 5000, Argentina
Research Site
Córdoba, X5016KEH, Argentina
Research Site
Paraná, 3100, Argentina
Research Site
Rosario, S2000DEJ, Argentina
Research Site
Clayton, 3168, Australia
Research Site
Namur, 5101, Belgium
Research Site
Athens, 11527, Greece
Research Site
Thessaloniki, 54642, Greece
Research Site
Thessaloniki, 56249, Greece
Research Site
Messina, 98125, Italy
Research Site
Naples, 80131, Italy
Research Site
Naples, 80138, Italy
Research Site
Roma, 00137, Italy
Research Site
Roma, 00161, Italy
Research Site
Vilnius, LT-08406, Lithuania
Research Site
Braga, 4710, Portugal
Research Site
Coimbra, 3000-602, Portugal
Research Site
Lisbon, 1169-045, Portugal
Research Site
Lisbon, 1500-650, Portugal
Research Site
Lisbon, 1998-018, Portugal
Research Site
Porto, 4099-001, Portugal
Research Site
Porto, 4200-319, Portugal
Research Site
Viana do Castelo, 4901-858, Portugal
Research Site
Badalona, 08916, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Seville, 41009, Spain
Research Site
Seville, 41013, Spain
Research Site
Hanoi, 100000, Vietnam
Research Site
Hanoi, 10000, Vietnam
Research Site
Hà Nội, 100000, Vietnam
Research Site
Hochiminh, 700000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking only applies to the double-blind, randomized maintenance phase of 16 weeks.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 31, 2022
First Posted
March 4, 2022
Study Start
July 1, 2022
Primary Completion (Estimated)
August 14, 2026
Study Completion (Estimated)
August 19, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.