NCT04840550

Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs

A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.

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 25 mg, lansoprazole 15 mg).

Conditions

• Preventive Peptic Ulcer

Interventions

Type	Name	Description
DRUG	Lansoprazole 15 mg	Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
DRUG	Tegoprazan 25 mg	Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

Timeline

• Start date: 2021-05-07
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2021-04-12
• Last updated: 2023-07-14

Locations

2 sites across 1 country: South Korea