Clinical Trial: Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.
Detailed Summary: GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.
Sponsor: Green Cross Corporation
Current Primary Outcome: A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy [ Time Frame: 2 weeks ]
The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2.
[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- A percentage of subjects showed significant improvement of stomach erosions by the endoscopy [ Time Frame: 2 weeks ]
The definition of "significant improvement" is the subject showed score changed from 2-4 to 1.
[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
- A percentage of subjects showed improvement of edema rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed score changed from 2 to 1.
- A percentage of subjects showed improvement of erythema rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
- A percentage of subjects showed improvement of hemorrhage rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
- A percentage of subjects showed improvement of gastric symptom rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
- Adverse Events [ Time Frame: 2 weeks ]
- Lab results(Hematology, Blood chemistry, Urinalysis) [ Time Frame: 2 weeks ]
- The results of physical examinations and Vital signs(body temperature, pulse) [ Time Frame: 2 weeks ]
- EKG results [ Time Frame: 2 weeks ]
Original Secondary Outcome:
- A percentage of subjects showed significant improvement of stomach erosions by the endoscopy [ Time Frame: 2 weeks ]
The definition of "significant improvement" is the subject showed score changed from 2-4 to 1.
[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
- A percentage of subjects showed improvement of edema rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed score changed from 2 to 1.
- A percentage of subjects showed improvement of erythema rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
- A percentage of subjects showed improvement of hemorrhage rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
- A percentage of subjects showed improvement of gastric symptom rating scale [ Time Frame: 2 weeks ]The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Information By: Green Cross Corporation
Dates:
Date Received: January 27, 2015
Date Started: September 2014
Date Completion: July 2015
Last Updated: July 1, 2015
Last Verified: July 2015
