This study is in progress, not accepting new patients

Study to Assess the Effects and Safety of NEXIUM for Maintenance of Healing in Erosive Esophagitis

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a study on Erosive Esophagitis GERD

Summary

Eligibility
for people ages 1-11 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around

Description

Summary

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

Details

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.

Keywords

Erosive Esophagitis, Gastroesophageal Reflux Disease, Healing, Maintenance, Esophagogastroduodenoscopy, Endoscopy, EGD, GERD, GERD in children, Gastroesophageal Reflux, Esomeprazole, Nexium 20mg, Nexium 10mg

Eligibility

You can join if…

Open to people ages 1-11

  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

You CAN'T join if...

  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

Locations

  • Research Site
    Sacramento California 95817 United States
  • Research Site
    Shreveport Louisiana 71103 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
Links
Sign up for this study
ID
NCT05267613
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 53 people participating
Last Updated