Trials / Completed
CompletedNCT04022096
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 351 (actual)
- Sponsor
- HK inno.N Corporation · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.
Detailed description
This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tegoprazan 25mg QD | Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months. |
| DRUG | Lansoprazole 15mg QD | Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months. |
Timeline
- Start date
- 2019-06-18
- Primary completion
- 2021-06-23
- Completion
- 2021-06-23
- First posted
- 2019-07-16
- Last updated
- 2023-01-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04022096. Inclusion in this directory is not an endorsement.