A Study on Vonoprazan in the Real-world Clinical Practice in China
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A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China
1 other identifier
observational
3,000
1 country
40
Brief Summary
The purpose of this study is to evaluate the safety of Vonoprazan by assessing all adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine clinical settings in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedStudy Start
First participant enrolled
December 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2023
CompletedOctober 25, 2023
October 1, 2023
2.5 years
August 4, 2020
October 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Reporting one or More AEs
Up to Week 10
Percentage of Participants Reporting one or More SAEs
Up to Week 10
Percentage of Participants Reporting one or More ADRs
ADRs refers to AE related to administered drug.
Up to Week 10
Secondary Outcomes (8)
Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment
Baseline up to Week 4
Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment
Baseline up to Week 8
Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms
Baseline and Week 4
Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment
Baseline up to Week 1
Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment
Baseline up to Week 1
- +3 more secondary outcomes
Study Arms (1)
Participants with RE
Participants diagnosed with RE who have received 20 milligram (mg) of vonoprazan in routine clinical practice, will be observed prospectively. Data will be collected from participants' medical records, self-reported questionnaires and recorded information on symptom via diaries.
Eligibility Criteria
Chinese participants who are prescribed with vonoprazan treatment in real-world clinical practice will be observed prospectively.
You may qualify if:
- Must be undergoing treatment with Vonoprazan.
- Must be at least 18 years old.
- Provide signed informed consent indicating that they (or a legally acceptable representative) have been informed of all pertinent aspects of the study and are willing to participate.
You may not qualify if:
- Are currently enrolled in or plan to participate in any other clinical trials (that is interventional study).
- Are contraindicated for Vonoprazan according to Product Package Insert.
- With a known hepatic function impairment, including jaundice.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (40)
Beijing Hospital
Beijing, Beijing Municipality, 000000, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Yongchuan Hospital of Chongqing Medical University
Yongchuan, Chongqing Municipality, 402160, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong, 518052, China
Zhuhai People's Hospital
Zhuhai, Guangdong, 519050, China
Heilongjiang Provincial Hospital (Nanshang)
Harbin, Heilongjiang, 150036, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, 450003, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Changshu No.2 People's Hospital
Changshu, Jiangsu, 215500, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210000, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nanjing First Hospital
Nanjing, Jiangsu, 210029, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, 266035, China
Weifang Peoples Hospital
Weifang, Shandong, 261041, China
Yantai Affiliated Hospital of Binzhou Medical College
Yantai, Shandong, 264100, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Chengdu Third People's Hospital
Chengdu, Sichuan, 610031, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
General Hospital of Tianjin
Tianjin, Tianjin Municipality, 300052, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310000, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The Affiliated Hospital of Medical School of Ningbo University
Ningbo, Zhejiang, 315105, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325000, China
The Second Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang, 32200, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 6, 2020
Study Start
December 24, 2020
Primary Completion
June 27, 2023
Study Completion
June 27, 2023
Last Updated
October 25, 2023
Record last verified: 2023-10
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.