Clinical Trial

A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Recruiting
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Summary
The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-10-24; most recent amendment 2025-05-21.
Trial Details
NCT Number NCT06660342
Lead Sponsor Phathom Pharmaceuticals, Inc.
Conditions Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection
Enrollment 728 participants
Start Date 2025-05-15
Primary Completion 2034-09 (estimated)
Study Completion 2034-09 (estimated)
Updated on ClinicalTrials.gov 2025-05-22