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"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223380

Enrollment

1119

Registered

2016-11-16

Start date

2016-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric or duodenal ulcers

Interventions

investigational material(s) Generic name etc : Vonoprazan 10 mg INN of investigational material : vonoprazan Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Inves

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants with a history of gastric or duodenal ulcers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety Percentage of participants who had one or more adverse drug reactions Timeframe; 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

Measure	Time frame
efficacy Percentage of Participants with Gastric Ulcers after the Start of Administration of Vonoprazan Tablets Timeframe; 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. efficacy Percentage of Participants with Duodenal Ulcers after the Start of Administration of Vonoprazan Tablets Timeframe; 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. efficacy Percentage of Participants with Hemorrhagic Lesions on Stomach after the Start of Administration of Vonoprazan Tablets Timeframe; Up to 12 months Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets. efficacy Percentage of Participants with Hemorrhagic Lesions on Duodenum after the Start of Administration of Vonoprazan Tablets Timeframe; Up to 12 months Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.	—

Measure

Time frame

efficacy Percentage of Participants with Gastric Ulcers after the Start of Administration of Vonoprazan Tablets Timeframe; 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. efficacy Percentage of Participants with Duodenal Ulcers after the Start of Administration of Vonoprazan Tablets Timeframe; 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. efficacy Percentage of Participants with Hemorrhagic Lesions on Stomach after the Start of Administration of Vonoprazan Tablets Timeframe; Up to 12 months Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets. efficacy Percentage of Participants with Hemorrhagic Lesions on Duodenum after the Start of Administration of Vonoprazan Tablets Timeframe; 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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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026