NCT04784910

Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.

Conditions

• Peptic Ulcer

Interventions

Type	Name	Description
DRUG	DWP14012 20mg	DWP14012 20mg, tablet, orally, once daily for up to 24 weeks
DRUG	Lansoprazole 15 mg	Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
DRUG	DWP14012 20mg placebo	DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
DRUG	Lansoprazole 15 mg placebo	Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

Timeline

• Start date: 2021-05-21
• Primary completion: 2023-11-27
• Completion: 2023-12-11
• First posted: 2021-03-05
• Last updated: 2024-07-08

Locations

1 site across 1 country: South Korea