Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial | NCT07731542

NCT07731542

Overview

NCT ID: NCT07731542
Lead Sponsor: Asian Institute of Gastroenterology, IndiaOTHER
Official Title: A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)
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.
Conditions

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Jan 10, 2026Actual
Primary Completion Date: Jan 10, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

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).

Pregnancy or Lactation

History of Consumption of alcohol or smoking

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 192Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Dr.Aniruddha Pratap singh, MD, DMContact
Doc.aniruddha85@gmail.com

Similar Studies

Participant Group/Arms

Combination TherapyExperimental

Vonoprazan + Itopride. 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 for FD and related conditions. The itopride dose of 150mg/day is the recommended dosage for dyspepsia based on prior clinical trials and is expected to improve gastric emptying and reduce postprandial distress symptoms without significant systemic side effects

Drug: Vonoprazan plus Itopride combination

Control Group (Monotherapy)Active Comparator

Participants receive: • Vonoprazan 20 mg orally once daily for 12 weeks. Purpose: Assess the effectiveness of vonoprazan monotherapy in relieving functional dyspepsia symptoms.

Drug: Vonoprazan