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

NCT06660342 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 728

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Vonoprazan

Oral tablet.

Sponsors & Collaborators

  • Phathom Pharmaceuticals, Inc.

    lead INDUSTRY

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2034-09-30
Completion
2034-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660342 on ClinicalTrials.gov