Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
2 other identifiers
observational
1,237
1 country
1
Brief Summary
The purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 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
March 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
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedResults Posted
Study results publicly available
October 23, 2019
CompletedJune 10, 2025
May 1, 2025
2.5 years
July 9, 2017
August 29, 2019
May 22, 2025
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 (11)
Endoscopic Relapse Rate
From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Baseline, Month 6 and at Month 12
- +6 more secondary outcomes
Study Arms (1)
Vonoprazan 10 mg or 20 mg
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
Interventions
Eligibility Criteria
The study population will consist of participants with a diagnosis of reflux esophagitis and received dose of vonoprazan in the routine medical care.
You may qualify if:
- \- Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis
You may not qualify if:
- Participants meeting the criteria of grade A to D according to the Los Angeles classification (Hoshihara's modification), by means of endoscopy at the initiation of maintenance therapy with vonoprazan tablets
- Participants with a previous history of hypersensitivity to ingredients in vonoprazan tablets
- Participants taking atazanavir sulfate or rilpivirine hydrochloride
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda Selected Site
Tokyo, Japan
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
March 1, 2016
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
June 10, 2025
Results First Posted
October 23, 2019
Record last verified: 2025-05
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.