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"

June 2, 2023 updated by: Takeda

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"

The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The drug being tested in this study is called Vonoprazan. Vonoprazan is being tested to treat people who have a history of gastric or duodenal ulcers.

This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving NSAIDs.

The study will enroll approximately 1000 participants.

• Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

Study Type

Observational

Enrollment (Actual)

1304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tokyo, Japan
        • Takeda Selected Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will consist of participants with a historical diagnosis of gastric or duodenal ulcers and during NSAIDs administration in the routine medical care.

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vonoprazan 10 mg
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.
Vonoprazan tablets
Other Names:
  • Takecab tablets
  • TAK-438

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

July 9, 2017

First Submitted That Met QC Criteria

July 9, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Vonoprazan-5005
  • JapicCTI-163436 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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