Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DWP14012 20mg DWP14012 20mg, tablet, orally, once daily |
Drug: DWP14012
tablet
Drug: DWP14012 placebo
tablet
Drug: Esomeprazole placebo
tablet
|
Experimental: DWP14012 40mg DWP14012 40mg, tablet, orally, once daily |
Drug: DWP14012
tablet
Drug: DWP14012 placebo
tablet
Drug: Esomeprazole placebo
tablet
|
Experimental: DWP14012 80mg DWP14012 40mg*2, tablet, orally, once daily |
Drug: DWP14012
tablet
Drug: DWP14012 placebo
tablet
Drug: Esomeprazole placebo
tablet
|
Active Comparator: Esomerpazole 40mg Esomerpazole 40mg, tablet, orally, once daily |
Drug: Esomeprazole
tablet
Other Names:
Drug: DWP14012 placebo
tablet
|
Outcome Measures
Primary Outcome Measures
- Ratio of subjects who were completely cured of mucosal defects by 8 weeks [8 weeks]
Secondary Outcome Measures
- Ratio of subjects who were completely cured of mucosal defects by 4 weeks [4 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults between 20 and 75 years old based on the date of written agreement
-
Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
-
Those who experienced symptoms of heartburn or acid reflux within the last 7 days
Exclusion Criteria:
-
Those who have undergone gastric acid suppression or gastric, esophageal surgery
-
Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hanyang University Medical Center | Sungdong-gu | Seoul | Korea, Republic of | 04763 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWP14012002