Endoscopic evidence of maintenance of healing with oral NEXIUM in patients 1 to 11 years old with erosive esophagitis.
- Conditions
- Erosive EsophagitisMedDRA version: 20.1Level: LLTClassification code: 10063657Term: Erosive esophagitis Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-505454-18-00
- Lead Sponsor
- Astrazeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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)., 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., For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase., 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., Patients must weigh = 10 kg., Patients may be male or female., 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., 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.
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)., Previous screening, or enrollment and randomization in the present study., 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, 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)., Previous total gastrectomy., 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., Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment., Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product, Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Maintenance phase:<br>• 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: Healing phase: • To assess the efficacy and safety of NEXIUM for the healing of EE in pediatric patients 1 to 11 years of age, Maintenance phase: • 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.
- Secondary Outcome Measures
Name Time Method 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;Secondary end point(s):• The percentage of days without rescue medication during the 8-week healing phase;Secondary end point(s):• 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.;Secondary end point(s):Maintenance phase: • The percentage of days without rescue medication during the 16-week maintenance phase