Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

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.

• Vonoprazan (Drug), also known as Takecab tablets, TAK-438: Vonoprazan tablets

Primary outcomes

• Percentage of Participants Who Had One or More Adverse Drug Reactions [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.

Secondary outcomes

• Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets [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.
• Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets [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.
• Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets [Up to 12 months]: Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.
• Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets [Up to 12 months]: Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.

Sex: All

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

Participant flow

Outcome results

• Percentage of Participants Who Had One or More Adverse Drug Reactions (Primary), Number, Percentage of Participants: Vonoprazan 10 mg 1.79
• Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.67
• Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.19
• Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.19
• Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.00

Adverse events

Time frame: Up to 12 months

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2017-06-02)
• Statistical Analysis Plan (PDF, 2019-08-07)

• Study Director, Study director, Takeda