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OpenTrials
Completed

NCT Number: NCT03562026

S-CEI of Nexium in Paediatric Patients

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

Completed

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Key information

Conditions

Peptic Ulcer, Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

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.

  • Development of adverse reactions which are unexpected from Precaution for Use
  • Development of adverse reactions
  • Efficacy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. frequency of adverse drug reactions (ADRs)

    Time frame: up to 8 weeks

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

  2. rate of improvement/worsening of symptoms

    Time frame: up to 8 weeks

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Specific Clinical Experience Investigation of Nexium in Paediatric Patients

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2018
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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