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

Description

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.

Conditions

Erosive Esophagitis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Erosive Esophagitis
Intervention / Treatment

-

Contacts and Locations

Fontana

Research Site, Fontana, California, United States, 92335

Orange

Research Site, Orange, California, United States, 92868

Sacramento

Research Site, Sacramento, California, United States, 95817

Miami

Research Site, Miami, Florida, United States, 33155

Orlando

Research Site, Orlando, Florida, United States, 32806

Downers Grove

Research Site, Downers Grove, Illinois, United States, 60515

Carmel

Research Site, Carmel, Indiana, United States, 46290

Springfield

Research Site, Springfield, Massachusetts, United States, 01199-1001

Akron

Research Site, Akron, Ohio, United States, 44308

Cleveland

Research Site, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

1 Year to 11 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-11-06