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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

More Asian Institute of Gastroenterology, India trials in India