Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Acute Gastritis
Chronic Gastritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA...
Eligibility Criteria
Inclusion
- Diagnosed with acute gastritis or chronic gastritis
- 1 or more erosions found in the gastroscope examination
- Age should be: 20≤age≤75
Exclusion
- A patient with peptic ulcer and a gastroesophageal reflux disease.
- Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation
- Had a surgery regarding gastroesophageal
- A patient with Zollinger-Ellison syndrome
- Had a medical history of a malignant tumor
- A patient who is currently taking anti-thrombotic drugs
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT01813812
Start Date
October 1 2010
Last Update
March 22 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744