Vonoprazan Alone vs With Itopride for Functional Dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The VIVA trial is a 12-week, randomized comparison between vonoprazan 20 mg alone and vonoprazan 20 mg plus itopride 50 mg three times daily in adults with functional dyspepsia. Participants are screened, confirmed for FD with normal endoscopy, and then randomized to one of the two treatment arms. They will be followed with symptom assessments, quality of life measures, and safety monitoring at baseline, week 4, week 8, and week 12. The study aims to determine if combining a potent acid-suppressor with a prokinetic provides superior relief of both acid-related and motility-related FD symptoms. Results could inform optimal management strategies for FD when both acid suppression and gastric motility are considered.

Why it matters

Who can join: the full rules

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

Where it's running

• Asian Institute of Gastroenterology/AIG Hospitals
  Hyderabad, Telangana, India Recruiting

Study contacts

• Study coordinator: Dr.Aniruddha Pratap singh, MD, DM
• Email: Doc.aniruddha85@gmail.com
• Phone: 9004093248

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.