NCT03811080

Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 327 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.

Detailed description

This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).

Conditions

• Non-Erosive Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	DWP14012 A mg	The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
DRUG	DWP14012 B mg	The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.
DRUG	Placebo	The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.

Timeline

• Start date: 2019-02-07
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-01-22
• Last updated: 2019-06-25

Locations

1 site across 1 country: South Korea