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Potassium-Competitive Acid Blocker
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)
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
Pivotal Trial
Summary
This trial is testing vonoprazan, a daily medication, to see if it can relieve heartburn in people by reducing stomach acid over a short period. Vonoprazan has been shown to improve symptoms in patients with various stomach issues.
Eligible Conditions
- Functional Heartburn
- Heartburn
- Non-erosive Reflux Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Days Without Daytime or Nighttime Heartburn
Secondary study objectives
Percentage of Days Without Rescue Antacid Use
Side effects data
From 2017 Phase 4 trial • 3 Patients • NCT0311684133%
Viral upper respiratory tract
33%
Gastrointestinal disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vonoprazan 20mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
11 Previous Clinical Trials
3,411 Total Patients Enrolled
Medical DirectorStudy DirectorPhathom Pharmaceuticals
2,900 Previous Clinical Trials
8,089,658 Total Patients Enrolled