Special drug use surveillance of Vonoprazan for prevention of recurrence of gastric/duodenal ulcer in patients receiving low-dose aspirin: long-term use
Not Applicable
Completed
- Conditions
- Gastric or duodenal ulcers
- Registration Number
- JPRN-jRCT1080223380
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
In conclusion, the present surveillance raised no new concerns about the safety or efficacy of Vonoprazan Tablets for up to 12 months in patients on low-dose aspirin, compared to the clinical study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1119
Inclusion Criteria
Participants with a history of gastric or duodenal ulcers
Exclusion Criteria
Patients who meet any of the following criteria will not be included:
1.Participants with gastric or duodenal ulcer at initiation of administration of Vonoprazan therapy
2.Participants with active upper gastrointestinal hemorrhage at initiation of Vonoprazan therapy
3.Participants with a history of any hypersensitivity to ingredients in Vonoprazan Tablets
4.Participants receiving atazanavir sulfate or rilpivirine hydrochloride
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of participants who had one or more adverse drug reactions<br>Timeframe; Up to 12 months<br>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.
- Secondary Outcome Measures
Name Time Method