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

Methodology

Study Design:- The design compares vonoprazan 20mg monotherapy against vonoprazan 20mg + itopride 50mg (TID) combination therapy in a 1:1 allocation ratio. The total trial duration per participant is 12 weeks, consisting of a treatment period with regular follow-up assessments. The study's schematic is as follows:

• Patients with dyspeptic symptoms will be screened for eligibility. This includes obtaining informed consent, recording medical history, confirming FD diagnosis (including verification of a normal endoscopy result and H. pylori status), and a washout from disallowed medications. Baseline symptom assessments and lab tests will be done at the end of this phase.
• Randomization (Baseline) Visit: Eligible participants are randomly assigned to one of two treatment arms (described below) after baseline evaluations. Baseline symptom scores using Post prandial distress syndrome.
• Assessment and follow up: Participants take the assigned study medications for 12 weeks. Follow-up telephone calls or visits are scheduled at regular intervals Week 4, Week 8 and physical visit at 12 weeks for monitoring and assessment.

Methodology

Study Design:- The design compares vonoprazan 20mg monotherapy against vonoprazan 20mg + itopride 50mg (TID) combination therapy in a 1:1 allocation ratio. The total trial duration per participant is 12 weeks, consisting of a treatment period with regular follow-up assessments. The study's schematic is as follows:

• Patients with dyspeptic symptoms will be screened for eligibility. This includes obtaining informed consent, recording medical history, confirming FD diagnosis (including verification of a normal endoscopy result and H. pylori status), and a washout from disallowed medications. Baseline symptom assessments and lab tests will be done at the end of this phase.
• Randomization (Baseline) Visit: Eligible participants are randomly assigned to one of two treatment arms (described below) after baseline evaluations. Baseline symptom scores using LPDS.
• Assessment and follow up: Participants take the assigned study medications for 12 weeks. Follow-up telephone calls or visits are scheduled at regular intervals Week 4, Week 8 and physical visit at 12 weeks for monitoring and assessment.

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