Can a Two-Drug combo beat acid suppression alone for stomach discomfort?
NCT ID NCT07731542
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests whether adding itopride—a drug that helps the stomach empty faster—to the acid-reducing drug vonoprazan provides better symptom relief than vonoprazan alone in people with functional dyspepsia. Functional dyspepsia is a common condition causing upper stomach pain, fullness after meals, and feeling full quickly. About 192 adults with the condition will be randomly assigned to one of the two treatments for 12 weeks, and their symptoms and quality of life will be tracked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vonoprazan and itopride
- What this could lead to
- If it works, this could point toward a more effective treatment strategy for functional dyspepsia by combining acid suppression with a drug that improves stomach emptying.
- What could go wrong
- This is a relatively small, early-stage trial. The combination therapy may not provide significantly better symptom relief than vonoprazan alone, and itopride may cause side effects like diarrhea or abdominal pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Confirmed Functional Dyspepsia (FD): As per Rome IV criteria: Symptoms for ≥3 days/week over the last 3 months. 2. Prior endoscopy with normal findings or minor gastritis within the last 3 months. 3. Negative Helicobacter pylori test (Rapid urease test) or urea breath test 4. The patient should be off Proton pump inhibitors for 2 weeks Exclusion Criteria: 1. Evidence of structural/biochemical issues like peptic ulcer, erosive esophagitis, gastric/esophageal malignancy, pancreato-biliary disorders Overlapping functional GI Disorders: IBS 2. Uncontrolled systemic diseases (e.g., uncontrolled diabetes), major psychiatric disorders (e.g., severe depression), or neurological disorders affecting Gastrointestinal motility. 3. Use of medications that affect gastrointestinal motility or symptom perception (e.g., chronic opioid analgesics, anticholinergic drugs, benzodiazepines). 4. Pregnancy or Lactation 5. History of Consumption of alcohol or smoking
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asian Institute of Gastroenterology/AIG Hospitals
RECRUITINGHyderabad, Telangana, 500082, India
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