Trials / Unknown
UnknownNCT05701540
A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 338 (estimated)
- Sponsor
- HK inno.N Corporation · Industry
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
Detailed description
This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tegoprazan | Tegoprazan 50mg tablet |
| DRUG | Esomeprazole | Esomeprazole 20mg tablet 1. For patients with ERD: two Esomeprazole 20mg tablets 2. For patients with NERD: one Esomeprazole 20mg tablet |
Timeline
- Start date
- 2023-03-24
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2023-01-27
- Last updated
- 2023-08-03
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05701540. Inclusion in this directory is not an endorsement.