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 - SOLACE

AstraZeneca AB0 sites100 target enrollmentSeptember 3, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 3, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Patient must be 1 to 11 years of age, inclusive, at the time of their guardian signing the informed consent and the patient signing the informed assent (if applicable).
•2\. Patients must have a history of GERD for at least 3 months before the start of study treatment in the healing phase, as judged by the Investigator.
•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 (Grade 0 ie, no LA Grade A, B, C, or D) 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 IMP treatment.
•9\. Patient’s guardian must be capable of giving signed informed consent

•1 Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar, that the Investigator judges could be a risk for the patient or impact the ability to participate in the study (patients with neurological disabilities or hiatal hernia may be included if the Investigator considers it appropriate).
•2 Significant clinical illness within 4 weeks prior to the start of treatment, eg, unintentional weight loss, gastrointestinal bleeding requiring abstinence from food, jaundice, or any other signs indicating serious or malignant diseases.
•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 any of the following after enrollment in
•this study:
•\-PPIs (except for the IMPs)
•\- H2\-receptor antagonists
•\-Anticholinergic agents for gastrointestinal\-related diseases or symptoms
•\-Prostaglandin analog indicated for peptic ulcers (eg, misoprostol)