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"

Special drug use surveillance of Takecab tablets for "prevention of recurrence of gastric/duodenal ulcer in patients receiving non-steroidal anti-inflammatory drugs:long-term use"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223381

Enrollment

1304

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

A History of Gastric or Duodenal Ulcers

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants Who Had One or More Adverse Drug Reactions Time Frame: 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 Time Frame: Up to 12 months The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers. efficacy Percentage of Participants with Duodenal Ulcers Time Frame: Up to 12 months The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers. efficacy Percentage of Participants with Gastric Hemorrhagic Lesions Time Frame: Up to 12 months The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions. efficacy Percentage of Participants with Duodenal Hemorrhagic Lesions Time Frame: Up to 12 months The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.	—

Measure

Time frame

efficacy Percentage of Participants with Gastric Ulcers Time Frame: Up to 12 months The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers. efficacy Percentage of Participants with Duodenal Ulcers Time Frame: Up to 12 months The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers. efficacy Percentage of Participants with Gastric Hemorrhagic Lesions Time Frame: Up to 12 months The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions. efficacy Percentage of Participants with Duodenal Hemorrhagic Lesions Time Frame: Up to 12 months The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.

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Countries

Japan

Outcome results

None listed

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