← Back to Search

Proton Pump Inhibitor

Vonoprazan for Acid Reflux

Phase 1
Waitlist Available
Research Sponsored by Phathom Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7 and day 14
Awards & highlights

Study Summary

This trial will look at how well a new drug called vonoprazan works in treating symptoms of GERD in adolescents.

Eligible Conditions
  • Acid Reflux

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7 and day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 and day 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 Oral Clearance (CL/F) of Vonoprazan
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Area Under the Plasma Concentration-time Curve During the Dosing Interval τ (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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Vonoprazan 20 mgExperimental Treatment1 Intervention
Participants will receive vonoprazan 20 mg once daily for 14 days.
Group II: Vonoprazan 10 mgExperimental Treatment1 Intervention
Participants will receive vonoprazan 10 mg once daily 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
9 Previous Clinical Trials
3,416 Total Patients Enrolled
Medical DirectorStudy DirectorPhathom Pharmaceuticals
2,777 Previous Clinical Trials
8,063,456 Total Patients Enrolled

Frequently Asked Questions

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

What is the current enrollment figure for this research endeavor?

"The sponsor, Phathom Pharmaceuticals Inc., is seeking 18 eligible patients to complete this medical study. Two of the locations for research are University of South Alabama (USA) Physicians Group in Mobile, Alabama and Advanced Research Center - Elligo in Anaheim, California."

Answered by AI

In which sites can one access this research project?

"Patients may enrol in this trial at 6 designated medical centers, such as University of South Alabama (USA) Physicians Group in Mobile and Advanced Research Center - Elligo in Anaheim. Additionally, other sites include the University of Rochester Medical Center located in Rochester."

Answered by AI

Does Vonoprazan pose any health risks to individuals?

"Due to a lack of clinical data, Vonoprazan scored a 1 on our safety scale. As this is only in the first phase of trials, information related to efficacy and safety are limited."

Answered by AI

What are the prerequisites for participation in this trial?

"This medical trial is seeking 18 adolescents aged between 12 and 17 years-old with a diagnosis of gastroesophageal reflux. The necessary inclusion criteria for the study are: (1) body weight that falls within 5th to 95th percentile by age; (2) 3 months or longer history of GERD symptoms, based on physical examination, current signs/symptoms or diagnostic tests; (3) moderate heartburn severity according to the GERD Symptom Assessment - Investigator scale at screening; (4) ability to swallow medication; (5) parental consent and assent as needed ;and finally,(6 ) females"

Answered by AI

Are there any vacancies for potential participants in this clinical trial?

"Affirmative. According to records on clinicaltrials.gov, this medical trial is actively enrolling individuals as of November 18th 2022 - the date it was last updated. For successful completion of the study, 18 participants must be acquired from 6 distinct sites which opened for recruitment on May 9th 2022."

Answered by AI

Does the criteria for this clinical trial encompass those below sixty years of age?

"This investigation has established that the age range for patient participation is 12 to 17."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Infinite Clinical Trials
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

PPIs, Zantac, Pepcid etc.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
2022. "A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05343364.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top