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

Launched by ASTRAZENECA · Feb 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well different doses of a medication called Nexium can help maintain the healing of erosive esophagitis in children aged 1 to 11 years. Erosive esophagitis is a condition where the esophagus, the tube that connects the throat to the stomach, becomes inflamed and damaged, often due to acid reflux. The study aims to find out if Nexium can keep the esophagus healed after patients have already received initial treatment to heal it.

To participate in the trial, children must be between 1 and 11 years old and have a history of gastroesophageal reflux disease (GERD) for at least three months. They also need to have evidence of erosive esophagitis confirmed by a medical procedure called endoscopy before the study begins. Participants can expect to take Nexium for a specific period and will be monitored to see how well it works in keeping their esophagus healthy. It's important for families to know that there are certain health conditions that may exclude a child from participating, and a guardian will need to give consent for their child to join the study.

Gender

ALL

Eligibility criteria

• 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