A Study on Vonoprazan in the Real-world Clinical Practice in China
NCT ID: NCT04501627
Last Updated: 2023-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3000 participants
OBSERVATIONAL
2020-12-24
2023-06-27
Brief Summary
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Detailed Description
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The study will enroll approximately 3000 participants. The data will be collected through participants' medical records, self-reported questionnaires, and recorded information on symptom via diaries. All the participants will be assigned to a single observational cohort:
• Participants with RE
The multi-center trial will be conducted in China. The standard treatment will be of 4 weeks or it may reach up to 8 weeks if the dosing proves insufficient. All participants will be followed up for additional 2 weeks after the standard treatment. The overall duration of the study will be approximately 10 weeks.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Must be at least 18 years old.
3. 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.
Exclusion Criteria
2. Are contraindicated for Vonoprazan according to Product Package Insert.
3. With a known hepatic function impairment, including jaundice.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Yongchuan Hospital of Chongqing Medical University
Yongchuan, Chongqing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
Heilongjiang Provincial Hospital (Nanshang)
Harbin, Heilongjiang, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Changshu No.2 People's Hospital
Changshu, Jiangsu, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, China
Weifang Peoples Hospital
Weifang, Shandong, China
Yantai Affiliated Hospital of Binzhou Medical College
Yantai, Shandong, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Chengdu Third People's Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
General Hospital of Tianjin
Tianjin, Tianjin Municipality, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Affiliated Hospital of Medical School of Ningbo University
Ningbo, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang, China
Countries
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Related Links
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To obtain more information about this study, click this link.
Other Identifiers
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Vonoprazan-4007
Identifier Type: -
Identifier Source: org_study_id
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