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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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 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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Eligibility

Age eligible for study : 1 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-07-01

Primary completion: 2026-08-14

Study completion finish: 2026-11-06

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05267613

Intervention or treatment

DRUG: Nexium 20mg

DRUG: Nexium 10mg

Conditions

• Erosive Esophagitis

Condition: Erosive Esophagitis
DRUG: Nexium 20mg and other drugs
Clayton, Not Specified, Australia
Sponsor: AstraZeneca

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Find a site

Closest Location:

Research Site

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Research Site
Clayton, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Presence/absence of Erosive Esophagitis	Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase	Week 8 (end of healing phase)
Percentage of days without rescue medication	The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase	Week 8 (end of healing phase) and Week 16 (end of maintenance phase)

Frequently Asked Questions

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References

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