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Potassium-Competitive Acid Blocker

Vonoprazan for Heartburn

Phase 3
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 28
Awards & highlights

Study Summary

This trial will compare the effectiveness of vonoprazan, given at two different doses, to placebo in improving heartburn symptoms over four weeks in people with NERD.

Eligible Conditions
  • Heartburn
  • Non-erosive Reflux Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Days Without Daytime or Nighttime Heartburn
Secondary outcome measures
Percentage of Days Without Rescue Antacid Use

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

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Vonoprazan 20 mgExperimental Treatment1 Intervention
Participants will be administered vonoprazan at a dose of 20 mg QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to vonoprazan 20 mg in the Placebo-controlled Treatment Period will continue to take the same dose in the 20 week Extension Period.
Group II: Vonoprazan 10 mgExperimental Treatment1 Intervention
Participants will be administered vonoprazan at a dose of 10 mg QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to vonoprazan 10 mg in the Placebo-controlled Treatment Period will continue to take the same dose in the 20 week Extension Period.
Group III: PlaceboPlacebo Group1 Intervention
Participants will be administered the placebo QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to placebo in the Placebo-controlled Treatment Period will be re-randomized to receive either vonoprazan 10 mg QD or vonoprazan 20 mg QD in the 20 week Extension Period.
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
2,664 Total Patients Enrolled
1 Trials studying Heartburn
458 Patients Enrolled for Heartburn
Medical DirectorStudy DirectorPhathom Pharmaceuticals
2,777 Previous Clinical Trials
8,062,710 Total Patients Enrolled
4 Trials studying Heartburn
1,010 Patients Enrolled for Heartburn

Frequently Asked Questions

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

Could you elaborate on how many hospitals in North America are conducting this research?

"There are one hundred clinical trial sites nationwide, with locations in Wyoming, Rancho Cucamonga and Chapel Hill. Other participating states include: ____. To reduce the amount of travel required, it is best to select the location nearest you."

Answered by AI

Are there any vacancies in this trial for new volunteers?

"Unfortunately, this trial is not looking for any more patients at the current moment. The original posting was on January 17th of this year, with the most recent update being October 27th. Although this study isn't searching for candidates, there are other opportunities available from the 76 other trials that are recruiting."

Answered by AI

Are there any life-threatening risks associated with taking Vonoprazan?

"There is some efficacy data and multiple safety trials supporting Vonoprazan, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Other
Texas
North Carolina
How old are they?
18 - 65
What site did they apply to?
Northern California Research Corp
Biopharma Informatic, LLC
Peters Medical Research, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
1

What questions have other patients asked about this trial?

How long will the screening take place?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

i am hoping the clinical trial can help with my symptoms. i have tried over the counter drugs and prescription drugs and they all seem to fail.
PatientReceived no prior treatments
I've tried several types of medications for heartburn and non really help my heartburn.
PatientReceived 1 prior treatment
I've been having problems with heartburn at the start of the year and not a single over-the-counter medicine has had a major impact on me.
PatientReceived 1 prior treatment
I have tried dietary changes and medications, both OTC and prescription and I still have horrible heartburn and acid reflux all the time. It is also genetic so I want to stay ahead of it.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
2022. "A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05195528.
~239 spots leftby Apr 2025
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