Functioanl DyspepsiaNCT07731542
Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial
A study testing Vonoprazan plus Itopride combination and Vonoprazan in people with Functioanl Dyspepsia, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Functioanl Dyspepsia
- What is being tested?
- Vonoprazan plus Itopride combination and Vonoprazan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jan 2026to 10 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500082
Dr Mohan Ramchandani, MBBS MD DM, 04023378888 ext. 802, ramchandanimohan@gmail.com
Dr SHASHEENDRA YANAGANDULA, MBBS MS, 9676050769, shasheendra8@gmail.com
About this study
Official title: A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)
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.
Read the 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.
- Conditions
- Functioanl Dyspepsia
- Being tested
- Vonoprazan plus Itopride combination, Vonoprazan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan plus Itopride combinationDrug
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
VonoprazanDrug
Participants will receive vonoprazan 20 mg orally once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Vonoprazan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 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)
Measured: 12 weeks
Safety and Tolerability
Incidence of adverse events and laboratory abnormalities in each group.
Measured: 12 weeks
Rescue Medication Use
To calculate the frequency of antacid or analgesic use during the study period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start10 Jan 2026
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functioanl DyspepsiaStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Dr.Mohan Kumar Ramchandani, MD, DM, Study director, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731542
- Sponsor's protocol ID
- VIVA trial
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28366993Asaoka 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.
PubMed 28357069
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)
- ClinicalTrials.gov ID
- NCT07731542
- Acronym / sponsor ID
- VIVA trial
- Conditions
- Functioanl Dyspepsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Drug: Vonoprazan plus Itopride combinationVonoprazan + 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 |
| Control Group (Monotherapy) | Active comparator | Drug: VonoprazanParticipants receive: • Vonoprazan 20 mg orally once daily for 12 weeks. Purpose: Assess the effectiveness of vonoprazan monotherapy in relieving functional dyspepsia symptoms. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vonoprazan plus Itopride combinationParticipants 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 | Combination Therapy |
| VonoprazanParticipants will receive vonoprazan 20 mg orally once daily for 12 weeks | Drug | Control Group (Monotherapy) |
Primary outcome
Symptom Relief in Functional Dyspepsia
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Results publication: PubMed 28366993Kamiya 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.
- Results publication: PubMed 28357069Asaoka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr.Mohan Kumar Ramchandani, MD, DM study director
AIG Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vonoprazan plus Itopride combination and Vonoprazan in people with Functioanl Dyspepsia, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Aniruddha Pratap singh, MD, DM (9004093248, Doc.aniruddha85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Relief in Functional Dyspepsia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07731542, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.