Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
- Conditions
- Gastritis
- Interventions
- Drug: PlaceboDrug: GC6101A 150mgDrug: GC6101A 75mgDrug: GC6101A 37.5mg
- Registration Number
- NCT02353039
- Lead Sponsor
- Green Cross Corporation
- 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 Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Age is over 19 years old, men or women
- Patients diagnosed with acute or chronic gastritis by gastroscopy
- Patients with one or more erosions found by gastroscopy
- Signed the informed consent forms
- Patients who is impossible to receive gastroscopy
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy)
- Patients with esophageal varix
- Patients with malignant neoplasm of gastrointestinal tract
- Patients with thrombosis or administered with anti-thrombotic drugs
- Patients with consumption coagulopathy
- Patients administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks
- Patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment
- Allergic or hypersensitive to any of the ingredients in the test products
- Pregnant or lactating female
- Patients who have abnormal baseline laboratory test result
- Patients taking other investigational drugs within 30 days prior to the study.
- Patients with Zollinger-Ellison syndrome
- Patients that investigators consider ineligible for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administer placebo t.i.d for 2 weeks. GC6101A 150mg GC6101A 150mg Administer 50mg of GC6101A t.i.d for 2 weeks. GC6101A 75mg GC6101A 75mg Administer 25mg of GC6101A t.i.d for 2 weeks. GC6101A 37.5mg GC6101A 37.5mg Administer 12.5mg of GC6101A t.i.d for 2 weeks.
- Primary Outcome Measures
Name Time Method A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy 2 weeks The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2.
\[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
- Secondary Outcome Measures
Name Time Method Adverse Events 2 weeks Lab results(Hematology, Blood chemistry, Urinalysis) 2 weeks A percentage of subjects showed significant improvement of stomach erosions by the endoscopy 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 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 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 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 2 weeks The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
The results of physical examinations and Vital signs(body temperature, pulse) 2 weeks EKG results 2 weeks
Trial Locations
- Locations (14)
Inje University, Busan Paik Hospital of Korea
🇰🇷Busan, Korea, Republic of
Keimyung University, Dongsan Medical Center of Korea
🇰🇷Daegu, Korea, Republic of
Wonkwang University, Hospital of Korea
🇰🇷Iksan-si, Korea, Republic of
Seoul National University, Bundang Hospital of Korea
🇰🇷Seongnam-si, Korea, Republic of
Chungang University, Hospital of Korea
🇰🇷Seoul, Korea, Republic of
Ewha Womans University, Medical Center of Korea
🇰🇷Seoul, Korea, Republic of
Inje University, Seoul Paik Hospital of Korea
🇰🇷Seoul, Korea, Republic of
Kankbuk Samsung Medical Center of Korea
🇰🇷Seoul, Korea, Republic of
Korea University, Guro Hospital of Korea
🇰🇷Seoul, Korea, Republic of
The Catholic University, Seoul St. Mary's Hospital of Korea
🇰🇷Seoul, Korea, Republic of
Seoul National University, Hospital of Korea
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University, Seoul Hospital of Korea
🇰🇷Seoul, Korea, Republic of
Yonsei University, Gangnam Severance Hospital of Korea
🇰🇷Seoul, Korea, Republic of
Ajou University, Medical Center of Korea
🇰🇷Suwon-si, Korea, Republic of