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Vonoprazan for gastroesophageal reflux disease: Study protocol for a pragmatic, crossover-cluster, randomized controlled trail

Vonoprazan for gastroesophageal reflux disease: Study protocol for a pragmatic, crossover-cluster, randomized controlled trail

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069857
Enrollment
Unknown
Registered
2023-03-28
Start date
2023-03-31
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux disease

Interventions

A regimen:vonoprazan 20mg p.o. before or after breakfast
B regimen:vonoprazan 20mg p.o. before or after dinner
C regimen:vonoprazan 20mg p.o. before or after breakfast, and before or after dinner

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)=18 years old 2)Patients having completed upper gastrointestinal endoscopy in the past one year 3)Patients with typical symptoms for at least one month and GERD-Q=8; or patients with untypical symptoms for at least one month and erosive esophagitis grade B/C/D; 4)Adherence to the allocated regimens and the follow-up procedure

Exclusion criteria

Exclusion criteria: 1)Patients with acute peptic ulcer, previous gastric or esophageal surgery history; 3)Patients with serious diseases such as hepatic failure, renal insufficiency and cancers; 4)Pregnant and lactating women; 5)Patients with communication and coordination disorders

Design outcomes

Primary

MeasureTime frame
The rate of symptom relief;The healing rate of esophageal mucosa;

Secondary

MeasureTime frame
The score of quality of life;

Countries

China

Contacts

Public ContactHou Xiaohua

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

houxh@hust.edu.cn13035143646

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026