Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
NCT ID: NCT05267613
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2022-07-01
2027-09-06
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nexium - high dose
Arm 1 (High dose = Healing dose)
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.
Nexium - Low dose
Arm 2 (Low dose = ½ healing dose)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
1 Year
11 Years
ALL
No
Sponsors
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IQVIA RDS Inc.
INDUSTRY
Calyx
UNKNOWN
Laboratory Corporation of America
INDUSTRY
Medidata Solutions
INDUSTRY
Thermo Fisher Scientific, Inc
INDUSTRY
CISCRP
INDUSTRY
Quipment Inc.
UNKNOWN
Little Journey Ltd.
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Mobile, Alabama, United States
Research Site
Fontana, California, United States
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Orange, California, United States
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Sacramento, California, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Downers Grove, Illinois, United States
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Carmel, Indiana, United States
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Springfield, Massachusetts, United States
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The Bronx, New York, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Milwaukee, Wisconsin, United States
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Córdoba, , Argentina
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Córdoba, , Argentina
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Paraná, , Argentina
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Rosario, , Argentina
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Clayton, , Australia
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North Adelaide, , Australia
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Brussels, , Belgium
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Namur, , Belgium
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Athens, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Messina, , Italy
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Napoli, , Italy
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Napoli, , Italy
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Roma, , Italy
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Roma, , Italy
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Braga, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Viana do Castelo, , Portugal
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Novosibirsk, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Badalona, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Seville, , Spain
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Hochiminh, , Vietnam
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2023-505454-18-00
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002515-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9612C09998
Identifier Type: -
Identifier Source: org_study_id