NCT02556021

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CJ-12420 in Patients With Non-erosive Reflux Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: HK inno.N Corporation · 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 CJ-12420, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4

Detailed description

This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo). All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daily symptom in a subject diary on a daily basis.

Conditions

• Non-erosive Reflux Disease

Interventions

Type	Name	Description
DRUG	CJ-12420 50mg	CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
DRUG	CJ-12420 100mg	CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
DRUG	Placebo	Placebo, tablet, once daily, oral administration for up to 4 weeks

Timeline

• Start date: 2015-09-22
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-09-22
• Last updated: 2018-04-04

Locations

1 site across 1 country: South Korea