Peptic Ulcer, Gastroesophageal Reflux Clinical Trial
Official title:
Specific Clinical Experience Investigation of Nexium in Paediatric Patients
NCT number | NCT03562026 |
Other study ID # | D961WC00002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 28, 2018 |
Est. completion date | November 5, 2020 |
Verified date | September 2021 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch
Status | Completed |
Enrollment | 240 |
Est. completion date | November 5, 2020 |
Est. primary completion date | November 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Japan | Research Site | Aichi | |
Japan | Research Site | Akita | |
Japan | Research Site | Chiba | |
Japan | Research Site | Ehime | |
Japan | Research Site | Fukui | |
Japan | Research Site | Fukuoka | |
Japan | Research Site | Fukushima | |
Japan | Research Site | Gifu | |
Japan | Research Site | Gunma | |
Japan | Research Site | Hiroshima | |
Japan | Research Site | Hokkaido | |
Japan | Research Site | Hyogo | |
Japan | Research Site | Ibaraki | |
Japan | Research Site | Iwate | |
Japan | Research Site | Kagawa | |
Japan | Research Site | Kanagawa | |
Japan | Research Site | Kochi | |
Japan | Research Site | Kumamoto | |
Japan | Research Site | Mie | |
Japan | Research Site | Miyagi | |
Japan | Research Site | Nagano | |
Japan | Research Site | Nagasaki | |
Japan | Research Site | Osaka | |
Japan | Research Site | Saga | |
Japan | Research Site | Saitama | |
Japan | Research Site | Shizuoka | |
Japan | Research Site | Tochigi | |
Japan | Research Site | Tokushima | |
Japan | Research Site | Tokyo | |
Japan | Research Site | Toyama | |
Japan | Research Site | Yamagata |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | rate of improvement/worsening of symptoms | Rage of improvement/worsening of symptoms and cure rate on endoscopy | up to 8 weeks |