N/A
Completed N=1,119
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Gastric or Duodenal Ulcers
Source: ClinicalTrials.gov NCT03214094 ↗
Enrolled (actual)
1,119
Serious AEs
4.7%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Drug Reactions — 1.79 Percentage of Participants
Summary
The purpose of this survey is to investigate 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Drug Reactions |
1.79 | — |
| SECONDARY Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets |
0.67 | — |
| SECONDARY Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets |
0.19 | — |
| SECONDARY Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets |
0.19 | — |
| SECONDARY Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets |
0.00 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03214094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.