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Potassium-Competitive Acid Blocker

Vonoprazan for Functional 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

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

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

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 • NCT03116841

33%

Viral upper respiratory tract

33%

Gastrointestinal disorder

100%

80%

60%

40%

20%

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

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