- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214094
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Study Overview
Detailed Description
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.
This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.
The survey will enroll approximately 1,000 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
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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 hemorrhage at initiation vonoprazan therapy
- Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets
- Participants receiving atazanavir sulfate or rilpivirine hydrochloride
Study Plan
How is the study designed?
Design Details
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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets
Time Frame: Up to 12 months
|
Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.
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Up to 12 months
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Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets
Time Frame: Up to 12 months
|
Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.
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Up to 12 months
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Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets
Time Frame: Up to 12 months
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Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.
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Up to 12 months
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Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets
Time Frame: Up to 12 months
|
Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.
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Up to 12 months
|
Collaborators and Investigators
Sponsor
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-5004
- JapicCTI-163435 (REGISTRY: JapicCTI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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