Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis (EE)

R
Ryan T. Pitman, MS, MD

Primary Investigator

Enrolling By Invitation
1-11 years
All
Phase 3
100 participants needed
2 Locations

Brief description of study

The aim of this study is to determine if Nexium is safe and efficacious in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

Detailed description of study

Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verifiedve 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 withhe 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,boratory testing (including hematology, clinical chemistry, urinalysis), vitalgns (including blood pressure and pulse), and physical examination including weight.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Erosive Esophagitis, Riley
  • Age: Between 1 Year - 11 Years
  • Gender: All

Inclusion Criteria:
  1. Patient must be 1 to 11 years of age
  2. Patients must have a 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 endoscopyd within one week of the start of the healing phase.
  4. For the maintenance phase: Patients must have completed the healing phase and havedoscopy-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) beforeg treatment.
  8. Sexually active patients must be abstinent or maintain effective contraception fromd consent day up to the last day of IMP treatment.
  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, orurological 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 (fromhe 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-receptorgonists 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 weeksbefore enrollment.
  7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of thehe product
  8. Involvement in the planning and/or conduct of the study (applies to both AstraZenecad/or staff at the study site).
  9. Judgment by the Investigator that the patient should not participate in the study ifhe patient or guardian is unlikely to comply with study procedures, restrictions, andquirements
  10. Previous screening, or enrollment and randomization in the present study

Updated on 13 Sep 2024. Study ID: D9612C09998, PGI-AZ-SOLACE, 14068
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