Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial (NCT07731542) | Clinical Trial Compass
RecruitingNot Applicable
Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial
India192 participantsStarted 2026-01-10
Plain-language 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.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed Functional Dyspepsia (FD): As per Rome IV criteria: Symptoms for ≥3 days/week over the last 3 months.
. Prior endoscopy with normal findings or minor gastritis within the last 3 months.
. Negative Helicobacter pylori test (Rapid urease test) or urea breath test
. The patient should be off Proton pump inhibitors for 2 weeks
Exclusion criteria
. Evidence of structural/biochemical issues like peptic ulcer, erosive esophagitis, gastric/esophageal malignancy, pancreato-biliary disorders Overlapping functional GI Disorders: IBS
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Uncontrolled systemic diseases (e.g., uncontrolled diabetes), major psychiatric disorders (e.g., severe depression), or neurological disorders affecting Gastrointestinal motility.
. Use of medications that affect gastrointestinal motility or symptom perception (e.g., chronic opioid analgesics, anticholinergic drugs, benzodiazepines).