A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
NCT07752407 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2026-08-07
Summary
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).
Conditions
- Symptomatic Non-erosive Gastroesophageal Reflux Disease
Interventions
- DRUG
-
Vonoprazan
Oral tablet.
- DRUG
-
Oral tablet.
Sponsors & Collaborators
-
Phathom Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-25
- Primary Completion
- 2027-10-20
- Completion
- 2028-01-19
- FDA Drug
- Yes
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