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"
2 other identifiers
observational
1,304
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 9, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedResults Posted
Study results publicly available
May 19, 2021
CompletedJune 7, 2023
June 1, 2023
3.7 years
July 9, 2017
April 27, 2021
June 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Percentage of Participants With Gastric Ulcers
Up to 12 months
Percentage of Participants With Duodenal Ulcers
Up to 12 months
Percentage of Participants With Gastric Hemorrhagic Lesions
Up to 12 months
Percentage of Participants With Duodenal Hemorrhagic Lesions
Up to 12 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- \- Participants with a history of gastric or duodenal ulcer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda Selected Site
Tokyo, Japan
Related Publications (1)
Kawai T, Suzuki C, Honda Y, Fernandez JL. Long-term safety and effectiveness of vonoprazan for prevention of gastric and duodenal ulcer recurrence in patients on nonsteroidal anti-inflammatory drugs in Japan: a 12-month post-marketing surveillance study. Expert Opin Drug Saf. 2023 Jan-Jun;22(5):425-431. doi: 10.1080/14740338.2023.2136163. Epub 2022 Oct 20.
PMID: 36264125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2017
First Posted
July 11, 2017
Study Start
September 1, 2016
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
June 7, 2023
Results First Posted
May 19, 2021
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.