NCT04341428

Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis

A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.

Conditions

• Healed Erosive Esophagitis

Interventions

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

Timeline

• Start date: 2020-07-02
• Primary completion: 2021-08-30
• Completion: 2021-12-30
• First posted: 2020-04-10
• Last updated: 2020-09-03

Locations

1 site across 1 country: South Korea