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Endoscopic evidence of maintenance of healing with oral NEXIUM in patients 1 to 11 years old with erosive esophagitis.
EU CTIS ID: 2023-505454-18-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Argentina
- Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Argentina; Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.