A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,000
- Locations
- 40
- Primary Endpoint
- Percentage of Participants Reporting one or More ADRs
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Percentage of Participants Reporting one or More ADRs
Time Frame: Up to Week 10
ADRs refers to AE related to administered drug.
Percentage of Participants Reporting one or More SAEs
Time Frame: Up to Week 10
Percentage of Participants Reporting one or More AEs
Time Frame: Up to Week 10
Secondary Outcomes
- Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment(Baseline up to Week 4)
- Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment(Baseline up to Week 1)
- 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(Baseline up to Week 1)
- Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment(Baseline up to Week 8)
- 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)
- 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)
- Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at Week 4(Baseline up to Week 4)