An observational study in Erosive Esophagitis, Heartburn and Symptomatic Non-erosive Gastroesophageal Reflux Disease, sponsored by Phathom Pharmaceuticals, Inc.. Recruiting at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Phathom Pharmaceuticals, Inc. · Observational
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.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's planned enrollment of 728 is below the median of 938 across 25 observational studies indexed under Heartburn.
Browse Heartburn studies →Phathom Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study aims to enroll a total of 728 pregnant women in the study population from the United States, with 364 women in each cohort. This sample size will afford the study the ability to detect a 3-fold increase in the prevalence of the primary outcome, MCM, in the exposed cohort with 80% power.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women who are exposed to vonoprazan during pregnancy.
Drug: Vonoprazan
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.
Oral tablet.
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
Number of Participants with Minor Congenital Malformations
Time frame: DOC to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births
Number of Participants who Experience Spontaneous Abortion (SAB)
Time frame: DOC to 19 gestational weeks
Number of Participants who Experience Stillbirth
Time frame: 20 gestational weeks to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Elective Termination
Time frame: DOC to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Preterm Birth
Time frame: DOC to 36 gestational weeks
Number of Participants who are Small for Gestational Age (SGA)
Time frame: At delivery of live birth (approximately 40 weeks)
Number of Participants who Experience Postnatal Growth Deficiency
Time frame: 4 Months and 12 Months from Birth
Number of Participants who Experience Infant Developmental Delay
Time frame: 4 Months and 12 Months from Birth
Plan to share: No
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Phathom Pharmaceuticals, Inc.