Acute and Chronic Gastric Inflammation Patients Clinical Trial
Official title:
A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation
| NCT number | NCT02386007 |
| Other study ID # | DW 3101_201 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | Phase 2 |
| First received | February 16, 2015 |
| Last updated | October 11, 2016 |
The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Adult males/females aged 20~75 years - Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents - Subjects who voluntarily agree to participate in this clinical test with written consent Exclusion Criteria: - Patients impossible gastroscopy - In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis - Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded) - Patients with malignant tumor on digestive organ - Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Daewon Pharmaceutical Co., Ltd. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The change of gastric erosion score | The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 0 1~2 3~5 More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness. |
14day±3 | No |