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RECRUITING

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

NCT06660342 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Vonoprazan

Study Locations (1)

North Carolina

  • PPD — Wilmington

Trial Details

FieldValue
Enrollment Target 728 participants
Start Date 2025-05-15
Est. Completion 2034-09

Sponsor

Phathom Pharmaceuticals

3 total trials

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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 728 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Phathom Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06660342 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06660342?

The interventions under investigation include: Vonoprazan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06660342?

This trial is sponsored by Phathom Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial