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

Official title

A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Symptom Relief in Functional Dyspepsia [Time frame: 12 weeks]

Secondary outcome measures (4)

• Quality of Life Improvement [Time frame: 12 weeks]
• Responder Rate [Time frame: 12 weeks]
• Safety and Tolerability [Time frame: 12 weeks]
• Rescue Medication Use [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

India · 1 center

• Asian Institute of Gastroenterology/AIG Hospitals — Hyderabad

Publications

• 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
• 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

Identifiers

NCT: NCT07731542 · VIVA trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗