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

Erosive Esophagitis Clinical Trial

— EE  

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

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
• Start date: July 1, 2022
• Est. completion date: November 6, 2026

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• 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 (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.

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

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

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)