Endoscopic evidence of maintenance of healing with oral NEXIUM in patients 1 to 11 years old with erosive esophagitis. - EE

Study identifier:D9612C09998

ClinicalTrials.gov identifier:NCT05267613

EudraCT identifier:2020-002515-21

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Erosive Esophagitis

Phase

Phase 3

Healthy volunteers

Study drug

Nexium 20mg, Nexium 10mg

Sex

All

Estimated Enrollment

100

Study type

Interventional

Age

1 Years - 11 Years

Date

Study Start Date: 01 Jul 2022

Estimated Primary Completion Date: 14 Aug 2026

Estimated Study Completion Date: 06 Nov 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Collaborators

IQVIA RDS Inc., Calyx, Labcorp Central Laboratory Services, Medidata Solutions, Thermo Fisher Scientific, CISCRP (Center for Information and Study on Clinical Research Participation), Quipment Inc., Little Journey Ltd.

Inclusion and exclusion criteria

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

Sort by status

No locations available

Arms	Assigned Interventions
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.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]