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

NCT07731542 | Recruiting DMC

• 1 other identifier: VIVA trial
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Functioanl Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• Quality of Life Improvement

  12 weeks

• Responder Rate

  12 weeks

• Safety and Tolerability

  12 weeks

• Rescue Medication Use

  12 weeks

Study Arms (2)

Combination Therapy

EXPERIMENTAL

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

Interventions

Vonoprazan plus Itopride combination DRUG

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

Combination Therapy

Vonoprazan DRUG

Participants will receive vonoprazan 20 mg orally once daily for 12 weeks

Control Group (Monotherapy)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500082, India

RECRUITING

Related Publications (2)

• Kamiya T, Shikano M, Kubota E, Mizoshita T, Wada T, Tanida S, Kataoka H, Adachi H, Hirako M, Okuda N, Joh T. A multicenter randomized trial comparing rabeprazole and itopride in patients with functional dyspepsia in Japan: the NAGOYA study. J Clin Biochem Nutr. 2017 Mar;60(2):130-135. doi: 10.3164/jcbn.16-106. Epub 2017 Feb 24.

  PMID: 28366993 RESULT

• Asaoka D, Nagahara A, Hojo M, Matsumoto K, Ueyama H, Matsumoto K, Izumi K, Takeda T, Komori H, Akazawa Y, Shimada Y, Osada T, Watanabe S. Efficacy of a potassium-competitive acid blocker for improving symptoms in patients with reflux esophagitis, non-erosive reflux disease, and functional dyspepsia. Biomed Rep. 2017 Feb;6(2):175-180. doi: 10.3892/br.2016.828. Epub 2016 Dec 15.

  PMID: 28357069 RESULT

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Study Officials

• Dr.Mohan Kumar Ramchandani, MD, DM

  AIG Hospitals

  STUDY DIRECTOR

Central Study Contacts

Dr.Aniruddha Pratap singh, MD, DM

CONTACT

9004093248; Doc.aniruddha85@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 28, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 10, 2027
• Last Updated: July 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)