Clinical trial NCT03811080: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-Erosive Gastroesophageal Reflux Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 327
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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 .

Primary outcomes:
measure: 1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week
timeFrame: 4 week
Secondary outcomes:
measure: Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
timeFrame: 2 week, 4 week
measure: Reflux disease symptom assessment using Subject diary
timeFrame: 4 week
measure: Quality of Life assessment using PAGI-QoL
timeFrame: 4 week
measure: Use of rescue medication
timeFrame: 4 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
References: