Non-Erosive Gastroesophageal Reflux Disease
Conditions
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).
Interventions
DRUGDWP14012 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.
DRUGDWP14012 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.
DRUGPlacebo
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.
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Reflux disease symptom assessment using RDQ(Reflux disease questionnaire) | 2 week, 4 week |
| Reflux disease symptom assessment using Subject diary | 4 week |
| Quality of Life assessment using PAGI-QoL | 4 week |
| Use of rescue medication | 4 week |
Countries
South Korea
Contacts
Primary ContactDaewoong Pharmaceutical Co. LTD.
Outcome results
None listed