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Proton Pump Inhibitor

Vonoprazan for Acid Reflux in Children

Verified Trial
Phase 1
Recruiting
Research Sponsored by Phathom Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participant must have a diagnosis of GERD prior to randomization and medical history of signs or symptoms of GERD for at least 3 months prior to screening, based on physical examination, current symptoms (eg, heartburn), or diagnostic tests (eg, pH or endoscopy). Notes in the medical records and/or other source documents, such as prior endoscopies, can be used to support the diagnosis and will be recorded in the electronic case report form (eCRF).
The participant must be able to swallow study drug tablet with water.
Must not have
The participant has used prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonist (H2RAs) within 7 days prior to randomization or requires use during the Treatment Period.
The participant has received other agents affecting digestive organs, including muscarinic antagonists (eg, hyoscyamine), prokinetics, oral anticholinergic agents, prostaglandins, bismuth from 30 days prior to Day 1 or requires their use during the course of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 7 and 14
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the effects of vonoprazan in children with GERD for potential treatment.

Who is the study for?
Children aged 6-11 with symptomatic GERD, weighing within the 5th to 95th percentile for their age. They must have had GERD symptoms for at least 3 months and be able to swallow tablets. Those who've used certain digestive medications recently or have severe kidney or liver issues can't join.
What is being tested?
The trial is testing vonoprazan (10 or 20 mg daily) in children with GERD to understand how the drug behaves in their bodies (pharmacokinetics). It's a study of dosage effectiveness and safety.
What are the potential side effects?
While not specified here, common side effects of similar drugs include headache, diarrhea, nausea, abdominal pain, and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with GERD and have had symptoms for at least 3 months.
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I can swallow pills with water.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken or need to take acid-reducing medication recently.
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I have not taken drugs for digestive issues like anticholinergics or bismuth in the last 30 days.
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I have taken or need to take atazanavir sulfate or rilpivirine hydrochloride recently.
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I need to be in the hospital or have surgery planned during the study, or had major surgery within the last 30 days.
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I have had surgery on my digestive system before.
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I am allergic to vonoprazan or its ingredients.
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I haven't eaten grapefruit, Seville oranges, certain vegetables like kale or broccoli, or charbroiled meats in the last 7 days.
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My kidney function is severely impaired.
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My liver function is significantly impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 7 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 7 and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent Plasma Clearance (CL/F) of Vonoprazan
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Area Under the Drug Concentration-time Curve (AUCτ) of Vonoprazan
+1 more

Side effects data

From 2017 Phase 4 trial • 3 Patients • NCT03116841
33%
Viral upper respiratory tract
33%
Gastrointestinal disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vonoprazan 20mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Vonoprazan 20mgExperimental Treatment1 Intervention
Participants will receive vonoprazan 20mg QD for 14 days.
Group II: Vonoprazan 10mgExperimental Treatment1 Intervention
Participants will receive vonoprazan 10mg QD for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vonoprazan
2019
Completed Phase 4
~12720

Find a Location

Who is running the clinical trial?

Phathom Pharmaceuticals, Inc.Lead Sponsor
11 Previous Clinical Trials
4,165 Total Patients Enrolled
~9 spots leftby Nov 2025