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Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial
Sponsor: Asian Institute of Gastroenterology, India
Summary
The VIVA trial is a 12-week, randomized, interventional study comparing vonoprazan monotherapy versus vonoprazan plus itopride combination therapy in adults with functional dyspepsia (FD). FD is a common digestive disorder causing upper stomach discomfort, fullness after meals, and early satiety. The study aims to determine if adding itopride, a prokinetic that improves stomach emptying, to vonoprazan, a strong acid-suppressing drug, provides better symptom relief than vonoprazan alone. Participants will be randomly assigned to receive either treatment, and their symptoms, quality of life, and safety outcomes will be monitored throughout the study. The trial will help guide the best management strategy for FD by targeting both acid-related and motility-related symptoms.
Official title: A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)
Key Details
Gender
All
Age Range
20 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
192
Start Date
2026-01-10
Completion Date
2027-02-10
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Interventions
Vonoprazan plus Itopride combination
Participants will receive vonoprazan 20 mg orally once daily (preferably in the morning) for 12 weeks, plus itopride 50 mg orally thrice daily before meals for 12 weeks. The vonoprazan dose of 20 mg daily is chosen as it is the standard dose shown to provide potent acid suppression
Vonoprazan
Participants will receive vonoprazan 20 mg orally once daily for 12 weeks
Locations (1)
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, India