Could a simple pill replace uncomfortable scopes for diagnosing acid reflux?
NCT ID NCT07707011
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This trial tests whether a 7-day course of the acid-blocking drug vonoprazan can guide treatment for adults with frequent heartburn or regurgitation as effectively as standard tests like endoscopy and 24-hour pH monitoring. Participants are randomly assigned to either the drug-test group or the standard-test group, and their symptoms are tracked over 4 weeks. The goal is to see if the simpler drug test can accurately identify who needs acid-suppressing therapy, potentially avoiding invasive procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vonoprazan (a potassium-competitive acid blocker) as a diagnostic test, followed by treatment with vonoprazan, omeprazole, or nortriptyline based on response
- What this could lead to
- If successful, this could offer a simpler, less invasive way to diagnose and treat acid reflux, potentially replacing uncomfortable tests like endoscopy and 24-hour pH monitoring.
- What could go wrong
- This is a relatively small trial (120 participants) and the PCAB test may not be as accurate as standard physiologic testing, leading to misdiagnosis or less effective treatment.
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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 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 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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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age between 18 and 70 years. * Presence of specific gastroesophageal reflux disease (GERD) symptoms, including heartburn, regurgitation, and/or esophageal chest pain, occurring at least 4 times per week for more than 4 weeks prior to enrollment. Exclusion Criteria: * Presence of GERD complications, including esophageal stricture and/or Barrett's esophagus. * Concomitant symptoms that may interfere with GERD treatment, such as frequent belching or rumination syndrome. * History of gastric or duodenal ulcers. * History of upper gastrointestinal surgery (involving the esophagus, stomach, or small intestine). * Use of any of the following medications within 4 weeks prior to enrollment: aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), mucoprotective agents, prokinetics, or neuromodulators. * Use of proton pump inhibitors (PPIs), histamine H2-receptor antagonists (H2RAs), or potassium-competitive acid blockers (PCABs) within 2 weeks prior to enrollment. (Note: Patients may become eligible if they complete a minimum 2-week washout period). * Any contraindications for ambulatory esophageal reflux monitoring. * Known history of hypersensitivity, allergy, or adverse reactions to the study medications: vonoprazan, omeprazole, or nortriptyline. * Pregnant or breastfeeding women.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700, Thailand
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