Status:
UNKNOWN
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Non-Erosive Gastroesophageal Reflux Disease
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT03811080
Start Date
February 7 2019
End Date
February 1 2020
Last Update
June 25 2019
Active Locations (1)
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1
Hanyang University Medical Center
Seoul, South Korea