A study to evaluate the effects of Nexium in Children with Erosive Esophagitis (EE)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

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:
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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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