RECRUITING

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

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Conditions

Erosive EsophagitisGastroesophageal Reflux DiseaseHealingMaintenanceEsophagogastroduodenoscopyEndoscopyEGDGERDGERD in children

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-01
Study Completion:2026-11-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05267613

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.

Ages Eligible for Study:1 Year to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Patient must be 1 to 11 years of age
  2. 2. Patients must have a clinical history of GERD for at least 3 months before the start of study
  3. 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. 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. 5. Patients must weigh ≥ 10 kg.
  6. 6. Patients may be male or female.
  7. 7. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
  8. 8. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of study intervention.
  9. 9. Patient's guardian must be capable of giving signed informed consent
  1. 1. Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
  2. 2. Significant clinical illness within 4 weeks prior to the start of treatment
  3. 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. 4. Previous total gastrectomy
  5. 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. 6. Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
  7. 7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
  8. 8. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  9. 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. 10. Previous screening, or enrollment and randomization in the present study

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Fontana, California, 92335
United States
Research Site
Orange, California, 92868
United States
Research Site
Sacramento, California, 95817
United States
Research Site
Miami, Florida, 33155
United States
Research Site
Orlando, Florida, 32806
United States
Research Site
Downers Grove, Illinois, 60515
United States
Research Site
Carmel, Indiana, 46290
United States
Research Site
Springfield, Massachusetts, 01199-1001
United States
Research Site
Akron, Ohio, 44308
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
Knoxville, Tennessee, 37916
United States
Research Site
Dallas, Texas, 75235
United States
Research Site
Salt Lake City, Utah, 84132
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01
Study Completion Date2026-11-06

Study Record Updates

Study Start Date2022-07-01
Study Completion Date2026-11-06

Terms related to this study

Keywords Provided by Researchers

  • Erosive Esophagitis
  • Gastroesophageal Reflux Disease
  • Healing
  • Maintenance
  • Esophagogastroduodenoscopy
  • Endoscopy
  • EGD
  • GERD
  • GERD in children

Additional Relevant MeSH Terms

  • Erosive Esophagitis