S-CEI of Nexium in Paediatric Patients

Specific Clinical Experience Investigation of Nexium in Paediatric Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03562026

Enrollment

240

Registered

2018-06-19

Start date

2018-06-28

Completion date

2020-11-05

Last updated

2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer, Gastroesophageal Reflux

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Japan

Outcome results