Status:
RECRUITING
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
IQVIA RDS Inc.
Calyx
Conditions:
Erosive Esophagitis
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
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.
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 Un...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 6 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05267613
Start Date
July 1 2022
End Date
September 6 2027
Last Update
November 6 2025
Active Locations (55)
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1
Research Site
Mobile, Alabama, United States, 36604
2
Research Site
Fontana, California, United States, 92335
3
Research Site
Orange, California, United States, 92868
4
Research Site
Sacramento, California, United States, 95817