S-CEI of Nexium in Paediatric Patients

Completed

• Conditions: Peptic Ulcer, Gastroesophageal Reflux

• Registration Number: NCT03562026
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2018-04-29
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-19
• Study Start: 2018-06-28
• Primary Completion: 2020-11-05
• Study Completion: 2020-11-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of adverse drug reactions (ADRs)	up to 8 weeks	Development of ADRs by unexpected from "Precautions for Use" of Nexium JPI, by SOC, by patient demography and by treatment
rate of improvement/worsening of symptoms	up to 8 weeks	Rage of improvement/worsening of symptoms and cure rate on endoscopy

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamagata, Japan