N/A
Completed N=1,304
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"
A History of Gastric or Duodenal Ulcers
Source: ClinicalTrials.gov NCT03214198 ↗
Enrolled (actual)
1,304
Serious AEs
1.3%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Drug Reactions — 0.71 Percentage of Participants
Summary
The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Drug Reactions |
0.71 | — |
| SECONDARY Percentage of Participants With Gastric Ulcers |
0.56 | — |
| SECONDARY Percentage of Participants With Duodenal Ulcers |
0.16 | — |
| SECONDARY Percentage of Participants With Gastric Hemorrhagic Lesions |
0.24 | — |
| SECONDARY Percentage of Participants With Duodenal Hemorrhagic Lesions |
0.08 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03214198). 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.