Clinical trial NCT03562026: S-CEI of Nexium in Paediatric Patients
Official title: Specific Clinical Experience Investigation of Nexium in Paediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peptic Ulcer, Gastroesophageal Reflux
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-06-19
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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

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.

Primary outcomes:
measure: frequency of adverse drug reactions (ADRs)
timeFrame: up to 8 weeks
measure: rate of improvement/worsening of symptoms
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
affiliation: AZKK
name: Toshihito Nakano
role: STUDY_DIRECTOR
References: