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

March 13, 2024 updated by: AstraZeneca

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Recruiting
        • Research Site
      • Córdoba, Argentina, X5016KEH
        • Recruiting
        • Research Site
      • Parana, Argentina, 3100
        • Recruiting
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Recruiting
        • Research Site
  • Australia
      • Clayton, Australia, 3168
        • Recruiting
        • Research Site
      • North Adelaide, Australia, 5006
        • Recruiting
        • Research Site
  • Belgium
      • Namur, Belgium, 5101
        • Recruiting
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 56249
        • Recruiting
        • Research Site
  • Italy
      • Messina, Italy, 98125
        • Recruiting
        • Research Site
      • Napoli, Italy, 80131
        • Recruiting
        • Research Site
      • Napoli, Italy, 80138
        • Recruiting
        • Research Site
      • Roma, Italy, 00137
        • Recruiting
        • Research Site
      • Roma, Italy, 00161
        • Recruiting
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, LT50009
        • Recruiting
        • Research Site
      • Vilnius, Lithuania, LT-08406
        • Recruiting
        • Research Site
  • Portugal
      • Braga, Portugal, 4710
        • Recruiting
        • Research Site
      • Coimbra, Portugal, 3000-602
        • Recruiting
        • Research Site
      • Lisboa, Portugal, 1998-018
        • Recruiting
        • Research Site
      • Lisboa, Portugal, 1500-650
        • Recruiting
        • Research Site
      • Lisboa, Portugal, 1169-045
        • Recruiting
        • Research Site
      • Porto, Portugal, 4099-001
        • Recruiting
        • Research Site
      • Porto, Portugal, 4200-319
        • Recruiting
        • Research Site
      • Viana do Castelo, Portugal, 4901-858
        • Recruiting
        • Research Site
  • Russian Federation
      • Novosibirsk, Russian Federation, 630007
        • Suspended
        • Research Site
      • Pyatigorsk, Russian Federation, 357502
        • Suspended
        • Research Site
      • Saint Petersburg, Russian Federation, 196240
        • Withdrawn
        • Research Site
      • Saint-Petersburg, Russian Federation, 196158
        • Suspended
        • Research Site
      • Tomsk, Russian Federation, 634009
        • Suspended
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • Research Site
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Research Site
      • Sevilla, Spain, 41013
        • Recruiting
        • Research Site
      • Sevilla, Spain, 41009
        • Recruiting
        • Research Site
  • United States
    • California
      • Fontana, California, United States, 92335
        • Not yet recruiting
        • Research Site
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Research Site
      • Sacramento, California, United States, 95817
        • Recruiting
        • Research Site
    • Florida
      • Miami, Florida, United States, 33155
        • Not yet recruiting
        • Research Site
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Research Site
    • Illinois
      • Downers Grove, Illinois, United States, 60515
        • Not yet recruiting
        • Research Site
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Recruiting
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199-1001
        • Not yet recruiting
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Not yet recruiting
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Not yet recruiting
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Not yet recruiting
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Research Site
  • Vietnam
      • Ha Noi, Vietnam, 100000
        • Recruiting
        • Research Site
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Research Site
      • Hanoi, Vietnam, 10000
        • Recruiting
        • Research Site
      • Hochiminh, Vietnam
        • Recruiting
        • Research Site

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.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nexium - high dose
Arm 1 (High dose = Healing dose)
Drug: Nexium 20mg
Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.
Active Comparator: Nexium - Low dose
Arm 2 (Low dose = ½ healing dose)
Drug: Nexium 10mg
Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence / absence of Erosive Esophagitis
Time Frame: Week 24 (end of 16-week maintenance phase)
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
Week 24 (end of 16-week maintenance phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/absence of Erosive Esophagitis
Time Frame: Week 8 (end of healing phase)
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase
Week 8 (end of healing phase)
Percentage of days without rescue medication
Time Frame: Week 8 (end of healing phase) and Week 16 (end of maintenance phase)
The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase
Week 8 (end of healing phase) and Week 16 (end of maintenance phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Laboratory Corporation of America
Medidata Solutions
IQVIA RDS Inc.
Calyx
Thermo Fisher Scientific, Inc
CISCRP (Center for Information and Study on Clinical Research Participation)
Quipment Inc.
Little Journey Ltd.

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 Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

August 14, 2026

Study Completion (Estimated)

November 6, 2026

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9612C09998
  • 2020-002515-21 (EudraCT Number)
  • 2023-505454-18-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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