S-CEI of Nexium in Paediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-28

Study Completion Date

2020-11-05

Brief Summary

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

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Detailed Description

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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

Conditions

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Peptic Ulcer, Gastroesophageal Reflux

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No