A Multi-Center, Randomized, Parallel, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy With DWC20155 or DWC20156 Monotherapy in Patients With Gastritis
| Registry | NCT03184415 |
|---|---|
| Status | Terminated - lack of efficacy |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 230 (Actual) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (Industry) |
| Conditions | Gastritis |
| Interventions | DWC20155, DWC20156, placebo of DWC20155, placebo of DWC20156 (Drug) |
| Dates | start 2017-07-03, primary completion 2018-05-17, completion 2018-05-17, first posted 2017-06-12, last updated 2019-06-26 |
| Locations | 1 site in South Korea |
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THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DWC20155/DWC20156 Combination Therapy | Experimental | Drug: DWC20155; Drug: DWC20156; Drug: placebo of DWC20155 | |
| DWC20155 Monotherapy | Active comparator | Drug: DWC20155; Drug: placebo of DWC20155; Drug: placebo of DWC20156 | |
| DWC20156 Monotherapy | Active comparator | Drug: DWC20156; Drug: placebo of DWC20155 |
Sex: All, ages: 19 Years to any
Inclusion Criteria: * Male of female of at least 19 years old * Patients diagnosed with acute or chronic gastritis by gastroscopy * Patients with one or more erosions found by gastroscopy Exclusion Criteria: * Patients with peptic ulcer and gastroesophageal reflux disease * Patients with previous gastrointestinal surgery * Patients with history of gastrointestinal cancer
| Facility | City | Country | Status |
|---|---|---|---|
| Daewoong pharmatceutical | Seoul | South Korea |