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Trial record 45 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

S-CEI of Nexium in Paediatric Patients

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ClinicalTrials.gov Identifier: NCT03562026
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease
Peptic Ulcer, Gastroesophageal Reflux

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Clinical Experience Investigation of Nexium in Paediatric Patients
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562026


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Toshihito Nakano AZKK

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03562026     History of Changes
Other Study ID Numbers: D961WC00002
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action