Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis (EE)

  • STATUS
    Recruiting
  • End date
    Nov 6, 2026
  • participants needed
    100
  • sponsor
    AstraZeneca
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Updated on 4 April 2023
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Summary

The aim of this study is to determine if Nexium is safe and efficacious in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

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.

Details
Condition Erosive Esophagitis
Treatment Nexium 20mg, Nexium 10mg
Clinical Study IdentifierNCT05267613
SponsorAstraZeneca
Last Modified on4 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient must be 1 to 11 years of age
Patients must have a 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 IMP treatment
Patient's guardian must be capable of giving signed informed consent

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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