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NCT03562026 Clinical Trial

S-CEI of Nexium in Paediatric Patients

Peptic Ulcer, Gastroesophageal Reflux Clinical Trial

Official title:
Specific Clinical Experience Investigation of Nexium in Paediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03562026
Other study ID # D961WC00002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 28, 2018
Est. completion date November 5, 2020

Study information
Verified date September 2021
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date November 5, 2020
Est. primary completion date November 5, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukui
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kanagawa
Japan Research Site Kochi
Japan Research Site Kumamoto
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Osaka
Japan Research Site Saga
Japan Research Site Saitama
Japan Research Site Shizuoka
Japan Research Site Tochigi
Japan Research Site Tokushima
Japan Research Site Tokyo
Japan Research Site Toyama
Japan Research Site Yamagata

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 up to 8 weeks
Primary rate of improvement/worsening of symptoms Rage of improvement/worsening of symptoms and cure rate on endoscopy up to 8 weeks

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