Erosive Esophagitis
Conditions
Keywords
Erosive Esophagitis, Gastroesophageal Reflux Disease, Healing, Maintenance, Esophagogastroduodenoscopy, Endoscopy, EGD, GERD, GERD in children
Brief 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.
Detailed 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.
Interventions
DRUGNexium 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.
DRUGNexium 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.
Sponsors
AstraZeneca
IQVIA RDS Inc.
Calyx
Laboratory Corporation of America
Medidata Solutions
Thermo Fisher Scientific, Inc
CISCRP
Quipment Inc.
Little Journey Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking only applies to the double-blind, randomized maintenance phase of 16 weeks.
Eligibility
Sex/Gender
ALL
Age
1 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence / absence of Erosive Esophagitis | Week 24 (end of 16-week maintenance phase) | Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of Erosive Esophagitis | Week 8 (end of healing phase) | Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase |
| Percentage of days without rescue medication | Week 8 (end of healing phase) and Week 16 (end of maintenance phase) | The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase |
Countries
Argentina, Australia, Belgium, Greece, Italy, Lithuania, Portugal, Spain, United States, Vietnam
Outcome results
None listed