NCT06121830

Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease (NERD)

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: 324 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the efficacy and safety of DWP14012 compared to a placebo following a once-daily oral dose of DWP14012 at 20 mg, 40 mg, or placebo for 4 weeks in patients with NERD.

Conditions

• Non-erosive Reflux Disease
• Non-Erosive Gastro-Esophageal Reflux Disease
• Non-Erosive Esophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	DWP14012 20mg	DWP14012 20mg, tablet, orally, once daily for up to 4 weeks
DRUG	DWP14012 40mg	DWP14012 40mg, tablet, orally, once daily for up to 4 weeks
DRUG	Placebo	Placebo, tablet, orally, once daily for up to 4 weeks

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2023-11-08
• Last updated: 2023-11-08

Locations

1 site across 1 country: South Korea