ESOMEPRAZOLE MAGNESIUM for Erosive esophagitis

Inclusion criteria

• {"criterion_text":"-Patient must be 1 to 11 years of age, inclusive, at the time of their guardian signing the informed consent and the patient signing the informed assent (if applicable)."}
• {"criterion_text":"-Patients must have a history of GERD for at least 3 months before the start of study treatment in the healing phase, as judged by the Investigator."}
• {"criterion_text":"-For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase."}
• {"criterion_text":"-For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE (Grade 0 ie, no LA Grade A, B, C, or D) at the 8-week endoscopy visit."}
• {"criterion_text":"-Patients must weigh ≥ 10 kg."}
• {"criterion_text":"-Patients may be male or female."}
• {"criterion_text":"-All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of IMP treatment. Sexually active postmenarcheal female patients must agree to the simultaneous use of 2 medically accepted methods of contraception from Day 1 until 3 days after the last dose of study medication. At least one method of contraception must be highly reliable (ie, can achieve a failure rate of < 1% per year), such as stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device in place for at least 3 months. The other method of contraception must be a barrier method, such as a diaphragm with spermicide or male partner's use of male condom with spermicide. NOTE: Prior to menarche, pregnancy testing is not required. However, the patient and their parent/guardian must be advised that, immediately upon menarche, the patient will be required to begin pregnancy testing and, if deemed necessary by the Investigator, initiate contraceptive use."}
• {"criterion_text":"-Patient’s guardian must be capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Assent forms will be signed by patients who are old enough to express their general understanding of the study as per local regulations."}

Exclusion criteria

• {"criterion_text":"-Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar, that the Investigator judges could be a risk for the patient or impact the ability to participate in the study (patients with neurological disabilities or hiatal hernia may be included if the Investigator considers it appropriate)."}
• {"criterion_text":"-Previous screening, or enrollment and randomization in the present study."}
• {"criterion_text":"-Significant clinical illness within 4 weeks prior to the start of treatment, eg, unintentional weight loss, gastrointestinal bleeding requiring abstinence from food, jaundice, or any other signs indicating serious or malignant diseases"}
• {"criterion_text":"-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)."}
• {"criterion_text":"-Previous total gastrectomy."}
• {"criterion_text":"-Anticipated need for concomitant therapy with any of the following after enrollment in this study: − PPIs (except for the IMPs) − H2-receptor antagonists − Anticholinergic agents for gastrointestinal-related diseases or symptoms − Prostaglandin analog indicated for peptic ulcers (eg, misoprostol) − Gastrointestinal promotility drugs − Bismuth-containing drugs − Mucosal protectants (antacids are accepted as rescue medication) − Any drug known to have the potential for a drug-drug interaction with NEXIUM (eg, atazanavir sulfate, nelfinavir mesylate, saquinavir mesylate, ritonavir, rilpivirine hydrochloride, diazepam, phenytoin, cilostazol, high-dose methotrexate, warfarin, tacrolimus hydrate [except external use], digoxin, methyldigoxin, itraconazole, ketoconazole, voriconazole, erlotinib, gefitinib, nilotinib, clopidogrel, rifampicin, clarithromycin, cisapride, citalopram, imipramine, clomipramine, and St John’s wort, etc). If relevant, please consult the current IB for details."}
• {"criterion_text":"-Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment."}
• {"criterion_text":"-Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product"}
• {"criterion_text":"-Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)."}
• {"criterion_text":"-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."}

Primary endpoints

• {"endpoint_text":"-Maintenance phase: • Presence/absence of EE for all patients by assessment of EGD at the end of the 16-week maintenance phase","definition_or_measurement_approach":"Assessment by esophagogastroduodenoscopy (EGD) at the end of the 16-week maintenance phase to determine presence/absence of erosive esophagitis."}
• {"endpoint_text":"-• Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory variables. Assessments related to AEs cover:  Occurrence/frequency  Relationship to IMP as assessed by the investigator  Intensity  Seriousness  Death  AEs leading to discontinuation of IMP Vital signs parameters include systolic and diastolic blood pressure, and pulse as well as body weight.","definition_or_measurement_approach":"Safety assessed by recording adverse events (occurrence/frequency, relationship to IMP, intensity, seriousness, death, AEs leading to discontinuation), vital signs (systolic/diastolic blood pressure, pulse, body weight) and clinical laboratory variables."}

Secondary endpoints

• {"endpoint_text":"-Healing phase: • Presence/absence of EE for all patients by assessment of EGD at the end of the 8-week healing phase","definition_or_measurement_approach":"Assessment by esophagogastroduodenoscopy (EGD) at the end of the 8-week healing phase to determine presence/absence of erosive esophagitis."}
• {"endpoint_text":"-• The percentage of days without rescue medication during the 8-week healing phase","definition_or_measurement_approach":"Calculated percentage of days during the 8-week healing phase where the patient did not use rescue medication."}
• {"endpoint_text":"-• Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory variables Assessments related to AEs cover:  Occurrence/frequency  Relationship to IMP as assessed by the investigator  Intensity  Seriousness  Death  AEs leading to discontinuation of IMP Vital signs parameters include systolic and diastolic blood pressure, and pulse as well as body weight.","definition_or_measurement_approach":"Same safety assessments as primary safety endpoint (AEs, vital signs, clinical laboratory variables)."}
• {"endpoint_text":"-Maintenance phase: • The percentage of days without rescue medication during the 16-week maintenance phase","definition_or_measurement_approach":"Calculated percentage of days during the 16-week maintenance phase where the patient did not use rescue medication."}

Methods

• Physician referral letters to clinicians (K2 / Physician Referral Letter) to identify eligible pediatric patients.
• Dr-to-Patient letters and Dr-to-Patient materials distributed via participating clinicians/sites.
• Parent brochures and patient posters (K2 recruitment materials) provided at sites and in relevant clinical settings.
• Site-led recruitment through pediatric gastroenterology clinics at listed hospitals in each Member State.
• Digital recruitment and retention via a tailored smartphone application provided by Little Journey Limited to aid patient recruitment and retention.
• Development and provision of patient-facing materials by Center For Information And Study On Clinical Research Participation Inc. (CISCRP).
• eConsent and electronic subject information procedures (CompleteConsent / eConsent system overview and security features) for remote or digital consent processes.

Greece

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

02-09-2025

Processing Time Days

544

Number Of Sites

3

Number Of Participants

10

Belgium

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

22-07-2025

Processing Time Days

502

Number Of Sites

1

Number Of Participants

4

Italy

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

719

Number Of Sites

5

Number Of Participants

18

Lithuania

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

12-08-2025

Processing Time Days

523

Number Of Sites

1

Number Of Participants

4

Portugal

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

529

Number Of Sites

8

Number Of Participants

12

Spain

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

540

Number Of Sites

4

Number Of Participants

6

Primary sponsor

Full Name

Astrazeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Iqvia Limited

Responsibilities

Various clinical trial services (sponsor duty codes: 1,12,2,5,8)

Name

Medidata Solutions Inc.

Responsibilities

eClinical / data capture services (sponsor duty code: 7)

Name

Fisher Clinical Services UK Limited

Responsibilities

Clinical supply chain management (IMP supply and re-supply)

Name

Labcorp Central Laboratory Services S.a.r.l.

Responsibilities

Central laboratory services

Third parties

• {"country":"France","full_name":"Quipment","duties_or_roles":"Rental or purchase of WIFI routers / SIM cards","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"Development of patient-facing materials for study participants","organisation_type":"Patient organisation/association"}
• {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Clinical Supply Chain Management (IMP supply and re-supply to study sites and returns for destruction to TF depos). Ancillary supplies","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duty code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Little Journey Limited","duties_or_roles":"Provider of tailored smartphone application to aid patient recruitment and retention. Patient-facing material.","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Licensing and translations of PRO questionnaires","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Limited","duties_or_roles":"Sponsor duties codes: 1, 12, 2, 5, 8","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Central laboratory services (sponsor duty code 4)","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Sponsor duties codes: 1, 12, 8","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Sponsor duty code: 3","organisation_type":"Pharmaceutical company"}