Vonoprazan for Acid Reflux
What You Need to Know Before You Apply
What is the purpose of this trial?
The main objective is to assess the efficacy of vonoprazan (10 mg as needed) compared to placebo (as needed) in relief of episodic heartburn at 2 hours that is sustained for 24 hours over 12 weeks of treatment in participants with non-erosive gastroesophageal reflux disease (GERD).
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have been diagnosed with non-erosive GERD and experience heartburn at least 4 days a week. Participants must be able to follow study instructions, keep an electronic diary, and women of childbearing age must use contraception.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares vonoprazan (10 mg as needed) to a placebo in relieving episodic heartburn over up to 24 weeks. Participants are randomly assigned to either group and take the medication when they have symptoms.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be administered open-label vonoprazan 10 mg once daily (QD) to be taken orally for 4 weeks during the 4-week run-in period. Participants will be administered vonoprazan 10 mg to be taken orally as needed at the onset of each heartburn episode (maximum of once in a 24-hour period) during the 12-week placebo-controlled timed assessment period and the subsequent 12-week placebo-controlled extension period.
Participants will be administered open-label vonoprazan 10 mg QD to be taken orally for 4 weeks during the 4-week run-in period. Participants will be administered placebo to be taken orally as needed at the onset of each heartburn episode (maximum of once in a 24-hour period) during the 12-week placebo-controlled timed assessment period and the subsequent 12-week placebo-controlled extension period.
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Who Is Running the Clinical Trial?
Phathom Pharmaceuticals, Inc.
Lead Sponsor
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