Peptic Ulcer, Gastroesophageal RefluxNCT03562026
S-CEI of Nexium in Paediatric Patients
An observational study of Peptic Ulcer, Gastroesophageal Reflux, run by AstraZeneca at 31 sites in Japan.
Trial summary
To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peptic Ulcer, Gastroesophageal Reflux
- How many people
- 240 participants
- Where
- 31 sitesJapan
- Study dates
- 28 Jun 2018to 5 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- 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", .
Who cannot join
- Patients with a history of hypersensitivity to components contained in this product.
- Patients during treatment with Atazanavir Sulfate and Rilpivirine hydrochloride.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Japan31 sites
Research Site
Aichi
Research Site
Akita
Research Site
Chiba
Research Site
Ehime
Research Site
Fukui
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Gifu
Research Site
Gunma
Research Site
Hiroshima
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Kagawa
Research Site
Kanagawa
Research Site
Kochi
Research Site
Kumamoto
Research Site
Mie
Research Site
Miyagi
Research Site
Nagano
Research Site
Nagasaki
Research Site
Numakunai
Research Site
Osaka
Research Site
Saga
Research Site
Saitama
Research Site
Shizuoka
Research Site
Tochigi
Research Site
Tokushima
Research Site
Tokyo
Research Site
Toyama
Research Site
Yamagata
About this study
Official title: Specific Clinical Experience Investigation of Nexium in Paediatric Patients
To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch
Read the 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
- Conditions
- Peptic Ulcer, Gastroesophageal Reflux
- Medical subject headings
- Peptic Ulcer, Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 8 weeks
rate of improvement/worsening of symptoms
Rage of improvement/worsening of symptoms and cure rate on endoscopy
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start28 Jun 2018
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer, Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshihito Nakano, Study director, AZKK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562026
- Sponsor's protocol ID
- D961WC00002
- Status last verified
- Sep 2021
- First submitted
- 29 Apr 2018
- Last updated
- 23 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Clinical Experience Investigation of Nexium in Paediatric Patients
- ClinicalTrials.gov ID
- NCT03562026
- Acronym / sponsor ID
- D961WC00002
- Conditions
- Peptic Ulcer, Gastroesophageal Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (2 listed)
- 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", .
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to components contained in this product.
- Patients during treatment with Atazanavir Sulfate and Rilpivirine hydrochloride.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
rate of improvement/worsening of symptoms
Time frame: up to 8 weeks
Rage of improvement/worsening of symptoms and cure rate on endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- CSR SynopsisLink provided by the sponsor.
- ProtocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshihito Nakano study director
AZKK
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peptic Ulcer, Gastroesophageal Reflux, run by AstraZeneca at 31 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of adverse drug reactions (ADRs) (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.