S-CEI of Nexium in Paediatric Patients

N/ACompletedNCT03562026

AstraZeneca240 enrolled

Overview

To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch

The objective of this investigation is to capture the followings when Nexium capsules or Nexium granules for suspension (single-dose package) are administered to pediatric patients in clinical practice after launch. 1. Development of adverse reactions which are unexpected from Precaution for Use 2. Development of adverse reactions 3. Efficacy

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Peptic Ulcer, Gastroesophageal Reflux

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 1(inclusive) to 15 (exclusive) years * Patients who have been prescribed Nexium for the first time for "gastric ulcer", "duodenal ulcer", "anastomotic ulcer", "reflux oesophagitis", "non-erosive reflux disease", or "Zollinger-Ellison syndrome", . Exclusion Criteria: * Patients with a history of hypersensitivity to components contained in this product. * Patients during treatment with Atazanavir Sulfate and Rilpivirine hydrochloride.

Locations (31)

Research Site

Aichi, Japan

Research Site

Outcomes

Primary Outcomes

frequency of adverse drug reactions (ADRs)

Development of ADRs by unexpected from "Precautions for Use" of Nexium JPI, by SOC, by patient demography and by treatment

Time frame: up to 8 weeks

rate of improvement/worsening of symptoms

Rage of improvement/worsening of symptoms and cure rate on endoscopy

Time frame: up to 8 weeks

Data from ClinicalTrials.gov

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