Trials / Recruiting
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 728 (estimated)
- Sponsor
- Phathom Pharmaceuticals, Inc. · Industry
- Sex
- Female
- Age
- 15 Years – 50 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Vonoprazan | Oral tablet. |
Timeline
- Start date
- 2025-05-15
- Primary completion
- 2034-09-01
- Completion
- 2034-09-01
- First posted
- 2024-10-28
- Last updated
- 2025-05-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06660342. Inclusion in this directory is not an endorsement.