- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214198
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"
Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The drug being tested in this study is called Vonoprazan. Vonoprazan is being tested to treat people who have a history of gastric or duodenal ulcers.
This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving NSAIDs.
The study will enroll approximately 1000 participants.
• Vonoprazan 10 mg
This multi-center observational survey will be conducted in Japan.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Tokyo, Japan
- Takeda Selected Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants with a history of gastric or duodenal ulcer
Exclusion Criteria:
- Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
- Participants with active upper gastrointestinal haemorrhage at initiation of vonoprazan therapy
- Participants with a history of hypersensitivity to any ingredients of vonoprazan Tablets
- Participants receiving atazanavir sulfate or rilpivirine hydrochloride
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vonoprazan 10 mg
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily.
Participants will receive interventions as part of routine medical care.
|
Vonoprazan tablets
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Had One or More Adverse Drug Reactions
Time Frame: Up to 12 months
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Adverse drug reaction refers to AE related to administered drug.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Gastric Ulcers
Time Frame: Up to 12 months
|
The presence or absence of onset of gastric ulcers was reported.
Reporting data was total percentage of participants with gastric ulcers.
|
Up to 12 months
|
Percentage of Participants With Duodenal Ulcers
Time Frame: Up to 12 months
|
The presence or absence of onset of duodenal ulcers was reported.
Reporting data was total percentage of participants with duodenal ulcers.
|
Up to 12 months
|
Percentage of Participants With Gastric Hemorrhagic Lesions
Time Frame: Up to 12 months
|
The presence or absence of onset of gastric hemorrhagic lesions was reported.
Reporting data was total percentage of participants with gastric hemorrhagic lesions.
|
Up to 12 months
|
Percentage of Participants With Duodenal Hemorrhagic Lesions
Time Frame: Up to 12 months
|
The presence or absence of onset of duodenal hemorrhagic lesions was reported.
Reporting data was total percentage of participants with duodenal hemorrhagic lesions.
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Study Director, Takeda
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vonoprazan-5005
- JapicCTI-163436 (Registry Identifier: JapicCTI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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