RecruitingNCT06660342

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

Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Sponsor

Phathom Pharmaceuticals, Inc.

Enrollment

728 participants

Start Date

May 15, 2025

Study Type

OBSERVATIONAL

Conditions

Helicobacter Pylori Infection Erosive Esophagitis Symptomatic Non-erosive Gastroesophageal Reflux Disease Heartburn

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.

Eligibility

Sex: FEMALEMin Age: 15 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vonoprazan for people with erosive esophagitis, heartburn, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 15 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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