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

NCT05267613 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-04-22

No results posted yet for this 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.

Conditions

  • Erosive Esophagitis

Interventions

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.

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.

Sponsors & Collaborators

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • Calyx

    collaborator UNKNOWN

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • Medidata Solutions

    collaborator INDUSTRY

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY

  • CISCRP

    collaborator INDUSTRY

  • Quipment Inc.

    collaborator UNKNOWN

  • Little Journey Ltd.

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2026-08-14
Completion
2026-08-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Greece
  • Italy
  • Lithuania
  • Portugal
  • Spain
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267613 on ClinicalTrials.gov