A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Public ClinicalTrials.gov record NCT05343364. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan (10 or 20 mg Once Daily) in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).
Study identification
- NCT ID
- NCT05343364
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 8, 2022
- Primary completion
- May 29, 2023
- Completion
- Jun 12, 2023
- Last update posted
- Apr 22, 2025
2022 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama (USA) Physicians Group | Mobile | Alabama | 36604-1541 | — |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center - Elligo | Anaheim | California | 92805 | — |
| Infinite Clinical Trials | Morrow | Georgia | 30260-2342 | — |
| Legacy Clinical Solutions: Tandem Clinical Research, LLC | Marrero | Louisiana | 70072-3151 | — |
| Boston Specialists | Boston | Massachusetts | 02111 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| PriMED Clinical Research | Dayton | Ohio | 45429 | — |
| ARC Clinical Research at Four Points | Austin | Texas | 78726 | — |
| Pediatric Gastro | El Paso | Texas | 79902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05343364, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05343364 live on ClinicalTrials.gov.