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

Phase 3

• Conditions: Non-Erosive Gastroesophageal Reflux Disease
• Interventions: Drug: DWP14012 A mg; Drug: DWP14012 B mg; Drug: Placebo

• Registration Number: NCT03811080
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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).

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Study Start: 2019-02-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-23
• Last Update Posted: 2019-06-25
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

1. Subjects aged between 20 and 75 years
2. Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD
3. Subjects who had experienced major symptom within 3 months
4. Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week
5. Subjects who is able to understand and follow the instructions
6. Subjects who voluntarily signed written informed consent form

Exclusion Criteria

1. Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy
2. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1
3. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months
4. Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery
5. Subjects with Zollinger-Ellison syndrome
6. Subjects with eosinophilic esophagitis
7. Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP14012 A mg	DWP14012 A mg	DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks
DWP14012 B mg	DWP14012 B mg	DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks
Placebo	Placebo	Placebo, tablet, once daily, oral administration for up to 4 weeks

Primary Outcome Measures

Name	Time	Method
1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week	4 week	defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)

Secondary Outcome Measures

Name	Time	Method
Quality of Life assessment using PAGI-QoL	4 week
Reflux disease symptom assessment using Subject diary	4 week
Use of rescue medication	4 week
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)	2 week, 4 week

Trial Locations

Locations (1)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of