S-CEI of Nexium in Paediatric Patients | NCT03562026

Studies
S-CEI of Nexium in Paediatric Patients

NCT03562026

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 23, 2021Actual

Enrollment

240Actual

Phase

Not provided

Conditions

Peptic Ulcer, Gastroesophageal Reflux

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2018Actual

Primary Completion Date

Nov 5, 2020Actual

Completion Date

Nov 5, 2020Actual

First Submitted Date

Apr 29, 2018

First Submission Date that Met QC Criteria

Jun 18, 2018

First Posted Date

Jun 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2021

Last Update Posted Date

Sep 23, 2021Actual

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
rate of improvement/worsening of symptoms	Rage of improvement/worsening of symptoms and cure rate on endoscopy	up to 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients aged 1(inclusive) to 15 (exclusive) years and 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", which are the indications of Nexium.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Toshihito Nakano	AZKK	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aichi			Japan
Research Site

Label	URL
CSR Synopsis	View source
Protocol	View source

Condition Browse Module

MeSH Terms

ID	Term
D010437	Peptic Ulcer
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided