NCT07731542 Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial
| NCT ID | NCT07731542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | Functioanl Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2027-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2026-01-10 with a primary completion date of 2027-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Dr.Mohan Kumar Ramchandani, MD, DM
STUDY DIRECTOR
AIG Hospitals
Frequently Asked Questions
Who can join the NCT07731542 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 50 Years, studying Functioanl Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07731542 currently recruiting?
Yes, NCT07731542 is actively recruiting participants. Contact the research team at Doc.aniruddha85@gmail.com for enrollment information.
Where is the NCT07731542 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT07731542 clinical trial?
NCT07731542 is sponsored by Asian Institute of Gastroenterology, India. The principal investigator is Dr.Mohan Kumar Ramchandani, MD, DM at AIG Hospitals. The trial plans to enroll 192 participants.