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

Non-Erosive Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811080
• Other study ID #: DW_DWP14012302
• Status: Recruiting
• Phase: Phase 3
• Start date: February 7, 2019
• Est. completion date: February 2020

Study information

• Verified date: June 2019
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Daewoong Pharmaceutical Co. LTD.
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 327
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Non-Erosive Gastroesophageal Reflux Disease

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week	defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)	4 week
Secondary	Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)		2 week, 4 week
Secondary	Reflux disease symptom assessment using Subject diary		4 week
Secondary	Quality of Life assessment using PAGI-QoL		4 week
Secondary	Use of rescue medication		4 week