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
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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
50 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Symptom Relief in Functional Dyspepsia — 12 weeks Proportion of participants achieving significant improvement in dyspepsia symptoms, assessed by the Leeds Dyspepsia Questionnaire (LPDS) score -The scale range from 0 to 7 7 is the highest score of anxiety/ depression, 0 is the least score.
Trial sites (1)
Facility
City
Region
Status
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad
Telangana
Recruiting
More Asian Institute of Gastroenterology, India trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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