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NCT06660342 · ClinicalTrials.gov registry record
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
A clinical trial of Heartburn and Erosive Esophagitis, sponsored by Phathom Pharmaceuticals.
- Recruiting
- Registry status
- 728
- Enrollment target
- 1
- Study location
NCT06660342 is a study of Heartburn and Erosive Esophagitis that is actively recruiting participants, run by Phathom Pharmaceuticals. The registered enrollment target is 728 participants, above the 339-participant average among 9 other Heartburn trials with a reported enrollment target (115% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06660342, a study of Heartburn and Erosive Esophagitis, is actively recruiting participants, sponsored by Phathom Pharmaceuticals.
- RECRUITING
- Registry status
- 728 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Vonoprazan
Study Locations (1)
North Carolina
- PPD - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 728 participants |
| Start Date | 2025-05-15 |
| Est. Completion | 2034-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06660342
The ClinicalTrials.gov registry entry for NCT06660342 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 728 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 339-participant average among 9 other Heartburn trials with a reported enrollment target (115% higher). The listed sponsor is Phathom Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Heartburn appearing as the primary indexed condition, and to 1 intervention - of which Vonoprazan is the first listed.
NCT06660342 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06660342 about?
NCT06660342 is a clinical study titled "A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring". 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 pr...
What is the current status of trial NCT06660342?
This trial is currently recruiting. The enrollment target is 728 participants. The study started on 2025-05-15. Estimated completion is 2034-09.
What conditions does trial NCT06660342 study?
This clinical trial studies the following conditions: Heartburn, Erosive Esophagitis, Helicobacter Pylori Infection, Symptomatic Non-erosive Gastroesophageal Reflux Disease.
What interventions are being tested in trial NCT06660342?
The interventions under investigation include: Vonoprazan (DRUG).
Who is sponsoring clinical trial NCT06660342?
This trial is sponsored by Phathom Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06660342 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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