Last updated 5 months ago
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
100 patients around the world
Available in Argentina, United States, Spain
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.
AstraZeneca
100Patients around the world
This study is for people with
Esophagitis
Requirements for the patient
To 11 Years
All Gender
Medical requirements
- Patient must be 1 to 11 years of agePatients must have a history of GERD for at least 3 months before the start of studyFor 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 IMP treatment.Patient's guardian must be capable of giving signed informed consent
- Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similarSignificant clinical illness within 4 weeks prior to the start of treatmentAny 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 gastrectomyAnticipated need for concomitant therapy with PPIs (except for the IMPs), H2-receptor antagonists and other drugs outlined in EC#5 after enrollment in this studyParticipation 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 productInvolvement 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 requirementsPrevious screening, or enrollment and randomization in the present study
StudyEE
SponsorAstraZeneca
Study typeInterventional
Conditions
Requirements
To 11 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05267613
