Recruiting

Vonoprazan

Sponsor:

Phathom Pharmaceuticals, Inc.

Code:

NCT06660342

Conditions

Erosive Esophagitis

Heartburn

Symptomatic Non-erosive Gastroesophageal Reflux Disease

Helicobacter Pylori Infection

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

Interventions

Vonoprazan

Study Details

Brief 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

Study ID

NCT06660342

Start date

May 15, 2025

Status verified date

May, 2025

Completion date

Sep, 2034

Anticipated

Primary completion date

Sep, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women 15 to 50 years of age.
  • Currently or recently pregnant.
  • Consent to participate.
  • Authorization for her health care provider(s) (HCP\[s\]) to provide data to the registry.
  • Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.
  • Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.

Exclusion Criteria:

  • Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
  • Exposure to known tetratogens and/or investigational medications during pregnancy.
  • Lost to follow-up.

Study Design

Enrollment

728 participants

Anticipated

Interventions and Outcome Measures

Arms

Exposed Cohort

Pregnant women who are exposed to vonoprazan during pregnancy.

Unexposed Cohort

Pregnant women who are not exposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.

Interventions

Vonoprazan

Oral tablet.

Primary outcome measure

  • Number of Participants with Major Congenital Malformations (MCMs) [ Time Frame: Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births ]

Central Contacts and Locations

Central contacts

VOQUEZNA Pregnancy Registry

1-866-609-1612DLVOQUEZNAPregnancyRegistry@ppd.com

Locations

PPD

Recruiting

Wilmington, North Carolina, United States, 28401

More Information

Sponsor

Phathom Pharmaceuticals, Inc.

Last update posted

May 22, 2025

Last verified

May, 2025

Keywords

  • Erosive Esophagitis
  • Heartburn
  • Symptomatic Non-erosive Gastroesophageal Reflux Disease
  • Helicobacter Pylori Infection
  • Pregnant Women
  • Fetal
  • Infant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Phathom Pharmaceuticals, Inc. on 2025-05-22.