Clinical trial NCT04501627: A Study on Vonoprazan in the Real-world Clinical Practice in China
Official title: A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagitis Peptic
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese participants who are prescribed with vonoprazan treatment in real-world clinical practice will be observed prospectively.

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.

Detailed description: This is a prospective, non-interventional study in Chinese participants with RE who are receiving or will receive the standard treatment of vonoprazan. This study will assess the safety and effectiveness of vonoprazan in the real-world clinical practice.

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.

Eligibility criteria: Inclusion Criteria:

1. Must be undergoing treatment with Vonoprazan.
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:

1. Are currently enrolled in or plan to participate in any other clinical trials (that is interventional study).
2. Are contraindicated for Vonoprazan according to Product Package Insert.
3. With a known hepatic function impairment, including jaundice.

Primary outcomes:
measure: Percentage of Participants Reporting one or More AEs
timeFrame: Up to Week 10
measure: Percentage of Participants Reporting one or More SAEs
timeFrame: Up to Week 10
measure: Percentage of Participants Reporting one or More ADRs
timeFrame: Up to Week 10
Secondary outcomes:
measure: Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment
timeFrame: Baseline up to Week 4
measure: Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment
timeFrame: Baseline up to Week 8
measure: Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms
timeFrame: Baseline and Week 4
measure: Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment
timeFrame: Baseline up to Week 1
measure: Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment
timeFrame: Baseline up to Week 1
measure: Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment
timeFrame: Baseline up to Week 1
measure: Percentage of Participants With Night Time Acid Regurgitation Symptom at Baseline Achieving Complete Night Time Acid Regurgitation Symptom Relief During the First Week of Treatment
timeFrame: Baseline up to Week 1
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at Week 4
timeFrame: Baseline up to Week 4
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Yongchuan
country: China
facility: Yongchuan Hospital of Chongqing Medical University
state: Chongqing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Huazhong University of Science and Technology Union Shenzhen Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Harbin
country: China
facility: Heilongjiang Provincial Hospital (Nanshang)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Changshu
country: China
facility: Changshu No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University (Qingdao)
state: Shandong
city: Weifang
country: China
facility: Weifang Peoples Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Affiliated Hospital of Binzhou Medical College
state: Shandong
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Third People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjing
country: China
facility: General Hospital of Tianjin
state: Tianjin
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated Hospital of Medical School of Ningbo University
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: