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

Completed

• Conditions: Gastric or Duodenal Ulcers
• Interventions: Drug: Vonoprazan

• Registration Number: NCT03214094
• Lead Sponsor: Takeda

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-09
• Study First Posted: 2017-07-11
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2020-02
• Results First Submitted: 2020-02-21
• Results First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Results First Posted: 2020-03-11
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1119

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vonoprazan 10 mg	Vonoprazan	The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan