S-CEI of Nexium in Paediatric Patients

AstraZeneca

Status: Completed

Conditions: Peptic Ulcer, Gastroesophageal Reflux

Study type: Observational

Funder types: Industry

Identifiers

NCT03562026

D961WC00002

Details and patient eligibility

About

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

Full description

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

Enrollment: 240 patients

Sex: All

Volunteers: No Healthy Volunteers

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.