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

RecruitingNAAges 20 Years - 50 YearsAllAsian Institute of Gastroenterology, India
NCT07731542 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Confirmed Functional Dyspepsia (FD): As per Rome IV criteria: Symptoms for ≥3 days/week over the last 3 months. 2. Prior endoscopy with normal findings or minor gastritis within the last 3 months. 3. Negative Helicobacter pylori test (Rapid urease test) or urea breath test 4. The patient should be off Proton pump inhibitors for 2 weeks Exclusion Criteria: 1. Evidence of structural/biochemical issues like peptic ulcer, erosive esophagitis, gastric/esophageal malignancy, pancreato-biliary disorders Overlapping functional GI Disorders: IBS 2. Uncontrolled systemic diseases (e.g., uncontrolled diabetes), major psychiatric disorders (e.g., severe depression), or neurological disorders affecting Gastrointestinal motility. 3. Use of medications that affect gastrointestinal motility or symptom perception (e.g., chronic opioid analgesics, anticholinergic drugs, benzodiazepines). 4. Pregnancy or Lactation 5. History of Consumption of alcohol or smoking
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What it tests

  • Vonoprazan plus Itopride combination
  • Vonoprazan
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Where

1 site
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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