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NCT05195528 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
A Phase 3 study, sponsored by Phathom Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 776
- Enrollment target
NCT05195528: Completed Phase 3 study, sponsored by Phathom Pharmaceuticals.
NCT05195528 is a Phase 3 study that has completed, run by Phathom Pharmaceuticals. The registered enrollment target is 776 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05195528, a Phase 3 study, has completed, sponsored by Phathom Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 776 participants
- Enrollment target
Study Summary
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily \[QD\]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.
Primary Outcome
Participants were assigned an electronic diary to complete twice daily, in the morning and evening. Diary day was considered heartburn-free if both morning and evening diary entries were heartburn-free and there was no reported use of rescue antacid, H2RAs, or PPIs.
Interventions
- DRUG Placebo
- DRUG Vonoprazan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 776 participants |
| Start Date | 2022-01-17 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 3 |
What the finished NCT05195528 record still lists
NCT05195528 is an interventional study that assigns participants to a tested intervention. The registered 776 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05195528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05195528 about?
NCT05195528 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)". The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily \[QD\]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.
What is the current status of trial NCT05195528?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 776 participants. The study started on 2022-01-17. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT05195528?
The interventions under investigation include: Placebo (DRUG), Vonoprazan (DRUG).
Who is sponsoring clinical trial NCT05195528?
This trial is sponsored by Phathom Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05195528's enrollment target sits among peer trials
776 439th of 2000 higher than 1,562 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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