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NCT04799158 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
A Phase 2 study, sponsored by Phathom Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 458
- Enrollment target
NCT04799158: Completed Phase 2 study, sponsored by Phathom Pharmaceuticals.
NCT04799158 is a Phase 2 study that has completed, run by Phathom Pharmaceuticals. The registered enrollment target is 458 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04799158, a Phase 2 study, has completed, sponsored by Phathom Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 458 participants
- Enrollment target
Study Summary
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.
Primary Outcome
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Interventions
- DRUG Placebo
- DRUG Vonoprazan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2022-01-17 |
| Phase | Phase 2 |
What the finished NCT04799158 record still lists
NCT04799158 is an interventional study that assigns participants to a tested intervention. The registered 458 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04799158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04799158 about?
NCT04799158 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease". The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety...
What is the current status of trial NCT04799158?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 458 participants. The study started on 2021-03-25. Estimated completion is 2022-01-17.
What interventions are being tested in trial NCT04799158?
The interventions under investigation include: Placebo (DRUG), Vonoprazan (DRUG).
Who is sponsoring clinical trial NCT04799158?
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 NCT04799158's enrollment target sits among peer trials
458 84th of 2000 higher than 1,917 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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