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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 7 and 14

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with GERD and have had symptoms for at least 3 months.

Select...

I can swallow pills with water.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 7 and 14

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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%

Study treatment Arm

Vonoprazan 20mg

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Phathom Pharmaceuticals, Inc.Lead Sponsor

9 Previous Clinical Trials

3,422 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to become part of this medical trial?

"Affirmative. The clinicaltrials.gov page for this trial clearly states that recruitment is still ongoing, with the post having been first published on November 1st 2023 and last updated on November 6th of the same year. 18 participants are needed from 3 medical sites in total."

Answered by AI

What is the participant number for this experiment?

"This research trial requires eighteen suitable candidates to take part, and they can sign up at PriMED Clinical Research (Dayton, Ohio) or Maspons Pediatric Gastro (El Paso, Texas). To be eligible for the study all participants must meet listed inclusion criteria."

Answered by AI

Does this experiment include elderly individuals in its participant pool?

"The requirements for participation stipulate that patients must be between 6 and 11 years old to qualify."

Answered by AI

Has Vonoprazan 10mg received the go-ahead from the FDA?

"There is minimal data to inform safety and efficacy of Vonoprazan 10mg, so it earned a rating of 1 out of 3."

Answered by AI

To what demographic are enrollment requirements applicable?

"For this clinical trial, 18 children between the ages of 6 and 11 with acid reflux are being accepted. In addition to age requirements they must have a body weight within the 5th through 95th percentile by age (according to National Center for Health Statistics data), show evidence of GERD symptoms in their medical history over 3 months prior to screening, demonstrate moderate GERD symptom severity at time of screening, be able to swallow study drug tablets with water, and have parental/legal guardian consent for participation and compliance with research procedures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease

2023. "A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106022.

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