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

Gastric or Duodenal Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214094
• Other study ID #: Vonoprazan-5004
• Secondary ID: JapicCTI-163435
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2020
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1119
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Ulcer
• Gastric or Duodenal Ulcers
• Recurrence
• Ulcer

Intervention

Drug:
• Vonoprazan
Vonoprazan tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Had One or More Adverse Drug Reactions	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.	Up to 12 months
Secondary	Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets	Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.	Up to 12 months
Secondary	Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets	Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.	Up to 12 months
Secondary	Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets	Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.	Up to 12 months
Secondary	Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets	Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.	Up to 12 months