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

Primary Purpose

Non-Erosive Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP14012 A mg
DWP14012 B mg
Placebo
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Erosive Gastroesophageal Reflux Disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Hanyang University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DWP14012 A mg

DWP14012 B mg

Placebo

Arm Description

DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks

DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks

Placebo, tablet, once daily, oral administration for up to 4 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Reflux disease symptom assessment using Subject diary
Quality of Life assessment using PAGI-QoL
Use of rescue medication

Full Information

First Posted
January 17, 2019
Last Updated
June 23, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT03811080
Brief Title
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Erosive Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
327 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DWP14012 A mg
Arm Type
Experimental
Arm Description
DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks
Arm Title
DWP14012 B mg
Arm Type
Experimental
Arm Description
DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, tablet, once daily, oral administration for up to 4 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012 A mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
DWP14012 B mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week
Description
defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Time Frame
2 week, 4 week
Title
Reflux disease symptom assessment using Subject diary
Time Frame
4 week
Title
Quality of Life assessment using PAGI-QoL
Time Frame
4 week
Title
Use of rescue medication
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged between 20 and 75 years Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD Subjects who had experienced major symptom within 3 months 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 Subjects who is able to understand and follow the instructions Subjects who voluntarily signed written informed consent form Exclusion Criteria: Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1 Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery Subjects with Zollinger-Ellison syndrome Subjects with eosinophilic esophagitis Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daewoong Pharmaceutical Co. LTD.
Facility Information:
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ohyoung Lee
Phone
82-2-2290-9652
Email
irb@hyumc.com
First Name & Middle Initial & Last Name & Degree
Ohoyoung Lee

12. IPD Sharing Statement

Learn more about this trial

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

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