NCT04501627

A Study on Vonoprazan in the Real-world Clinical Practice in China

A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagitis Peptic

Timeline

• Start date: 2020-12-24
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2020-08-06
• Last updated: 2023-10-25

Locations

40 sites across 1 country: China