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Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial

NCT07731542 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

  • Functioanl Dyspepsia

Interventions

DRUG

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

DRUG

Vonoprazan

Participants will receive vonoprazan 20 mg orally once daily for 12 weeks

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Dr.Mohan Kumar Ramchandani, MD, DM · AIG Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2027-01-10
Completion
2027-02-10

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731542 on ClinicalTrials.gov