An interventional study of Vonoprazan plus Itopride combination and Vonoprazan in Functioanl Dyspepsia, sponsored by Asian Institute of Gastroenterology, India. Recruiting at 1 site in India. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Treatment
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.
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:
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:
Exclusion Criteria:
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
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
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
Participants will receive vonoprazan 20 mg orally once daily for 12 weeks
Symptom Relief in Functional Dyspepsia
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.
Time frame: 12 weeks
Quality of Life Improvement
Change in Nepean Dyspepsia Index (NDI) scores , the scale range from 10 (Gastrointestinal symptoms effecting low level to the patient , 50 (Gastrointestinal symptoms affecting badly to the patinet) baseline to week 12.
Time frame: 12 weeks
Responder Rate
Proportion of participants with ≥50% improvement in Leuven post prandial distress score (nausea, belching, heartbun scores questionares 4 indicates severe, 0 indicates no symtoms)
Time frame: 12 weeks
Safety and Tolerability
Incidence of adverse events and laboratory abnormalities in each group.
Time frame: 12 weeks
Rescue Medication Use
To calculate the frequency of antacid or analgesic use during the study period.
Time frame: 12 weeks
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asian Institute of Gastroenterology, India