Acute Gastritis | A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
Acute Gastritis research study
What is the primary objective of this study?
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-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.
Who is eligible to participate?
Inclusion Criteria: - Diagnosed with acute gastritis or chronic gastritis - 1 or more erosions found in the gastroscope examination - Age should be: 20≤age≤75 Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DA-6034 45mgtwo tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
DA-6034 90mgtwo tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.
Rebamipide 300mgtwo tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.
Start Date: October 2010
Phase: Phase 3
Primary Outcome: The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).
Secondary Outcome: The number of erosions diagnosed by the gastroscope
Study sponsors, principal investigator, and references
Principal Investigator: Hyun Chae Jung, M.D., Ph.D.
Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.