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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05267613
Other study ID # D9612C09998
Secondary ID 2023-505454-18-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2022
Est. completion date November 6, 2026

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Esomeprazole (NEXIUMâ„¢) 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 6, 2026
Est. primary completion date August 14, 2026
Accepts healthy volunteers No
Gender All
Age group 1 Year to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Argentina Research Site Cordoba
Argentina Research Site Córdoba
Argentina Research Site Parana
Argentina Research Site Rosario
Australia Research Site Clayton
Australia Research Site North Adelaide
Belgium Research Site Namur
Greece Research Site Athens
Greece Research Site Thessaloniki
Greece Research Site Thessaloniki
Italy Research Site Messina
Italy Research Site Napoli
Italy Research Site Napoli
Italy Research Site Roma
Italy Research Site Roma
Lithuania Research Site Kaunas
Lithuania Research Site Vilnius
Portugal Research Site Braga
Portugal Research Site Coimbra
Portugal Research Site Lisboa
Portugal Research Site Lisboa
Portugal Research Site Lisboa
Portugal Research Site Porto
Portugal Research Site Porto
Portugal Research Site Viana do Castelo
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Pyatigorsk
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint-Petersburg
Russian Federation Research Site Tomsk
Spain Research Site Badalona
Spain Research Site Santiago de Compostela
Spain Research Site Sevilla
Spain Research Site Sevilla
United States Research Site Akron Ohio
United States Research Site Carmel Indiana
United States Research Site Cleveland Ohio
United States Research Site Dallas Texas
United States Research Site Downers Grove Illinois
United States Research Site Fontana California
United States Research Site Knoxville Tennessee
United States Research Site Miami Florida
United States Research Site Milwaukee Wisconsin
United States Research Site Orange California
United States Research Site Orlando Florida
United States Research Site Sacramento California
United States Research Site Salt Lake City Utah
United States Research Site Springfield Massachusetts
Vietnam Research Site Ha Noi
Vietnam Research Site Hanoi
Vietnam Research Site Hanoi
Vietnam Research Site Hochiminh

Sponsors (9)

Lead Sponsor Collaborator
AstraZeneca Calyx, CISCRP (Center for Information and Study on Clinical Research Participation), IQVIA RDS Inc., Laboratory Corporation of America, Little Journey Ltd., Medidata Solutions, Quipment Inc., Thermo Fisher Scientific, Inc

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Greece,  Italy,  Lithuania,  Portugal,  Russian Federation,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
See also
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Completed NCT01874535 - Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy Phase 4
Completed NCT00206180 - NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis Phase 4
Completed NCT01630746 - A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis Phase 3
Completed NCT01642615 - Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents Phase 2