Erosive Esophagitis MedDRA version: 20.1 Level: LLT Classification code 10063657 Term: Erosive esophagitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Nexium 10 mg gastro-resistant granules for oral suspension, sachet
Product Name: Esomeprazole magnesium, NEXIUM® 10mg
Pharmaceutical Form: Gastro-resistant granules for oral suspension in
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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). 2. 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. 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 (Grade 0 ie, no LA Grade A, B, C, or D) 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 IMP treatment. 9. Patient’s guardian must be capable of giving signed informed consent Assent forms will be signed by patients who are old enough to express their general understanding of the study as per local regulations. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 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). 2 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. 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Maintenance phase: To assess the efficacy and safety of NEXIUM for the maintenance of healing of EE in pediatric patients 1 to 11 years of age.;Secondary Objective: - To assess the efficacy and safety of NEXIUM for the healing of EE in pediatric patients 1 to 11 years of age - To assess symptoms during the 16-week maintenance phase;Primary end point(s): Maintenance phase: - Presence/absence of EE for all patients by assessment of EGD at the end of the 16-week maintenance phase. - 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. Assessments cover: Observed value, Absolute change from baseline over time - Laboratory parameters include clinical chemistry and hematology parameters as well as urinalysis. Assessments cover: Observed value and Absolute change from baseline over time;Timepoint(s) of evaluation of this end point: Week 16 post randomization for Maintenance phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Healing phase: - Presence/absence of EE for all patients by assessment of EGD at the end of the 8-week healing phase - The percentage of days without rescue medication during the 8-week healing phase - 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. Assessments cover: Observed value, Absolute change from baseline over time. Laboratory parameters include clinical chemistry and hematology parameters as well as urinalysis. Assessments cover: Observed value, Absolute change from baseline over time. Maintenance phase: -The percentage of days without rescue medication during the 16-week maintenance phase;Timepoint(s) of evaluation of this end point: Week 8 post enrollment for Healing phase endpoints and week 16 post randomization for Maintenance phase endpoints . | — |
Countries
Argentina, Australia, Belgium, Greece, Italy, Lithuania, Portugal, Russian Federation, Spain, United States, Vietnam
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed