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Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

Primary Purpose

Gastritis

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC6101A 37.5mg
GC6101A 75mg
GC6101A 150mg
Placebo
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Inje University, Busan Paik Hospital of KoreaRecruiting
  • Keimyung University, Dongsan Medical Center of KoreaRecruiting
  • Wonkwang University, Hospital of KoreaRecruiting
  • Seoul National University, Bundang Hospital of KoreaRecruiting
  • Chungang University, Hospital of KoreaRecruiting
  • Ewha Womans University, Medical Center of KoreaRecruiting
  • Inje University, Seoul Paik Hospital of KoreaRecruiting
  • Kankbuk Samsung Medical Center of KoreaRecruiting
  • Korea University, Guro Hospital of KoreaRecruiting
  • Seoul National University, Hospital of KoreaRecruiting
  • Soonchunhyang University, Seoul Hospital of Korea
  • The Catholic University, Seoul St. Mary's Hospital of KoreaRecruiting
  • Yonsei University, Gangnam Severance Hospital of KoreaRecruiting
  • Ajou University, Medical Center of KoreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

GC6101A 37.5mg

GC6101A 75mg

GC6101A 150mg

Placebo

Arm Description

Administer 12.5mg of GC6101A t.i.d for 2 weeks.

Administer 25mg of GC6101A t.i.d for 2 weeks.

Administer 50mg of GC6101A t.i.d for 2 weeks.

Administer placebo t.i.d for 2 weeks.

Outcomes

Primary Outcome Measures

A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
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

A percentage of subjects showed significant improvement of stomach erosions by the endoscopy
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
The definition of "improvement" is the subjects showed score changed from 2 to 1.
A percentage of subjects showed improvement of erythema rating scale
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
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
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Adverse Events
Lab results(Hematology, Blood chemistry, Urinalysis)
The results of physical examinations and Vital signs(body temperature, pulse)
EKG results

Full Information

First Posted
January 27, 2015
Last Updated
July 1, 2015
Sponsor
Green Cross Corporation
Collaborators
C&R Research, Inc., CRScube
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1. Study Identification

Unique Protocol Identification Number
NCT02353039
Brief Title
Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
Collaborators
C&R Research, Inc., CRScube

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GC6101A 37.5mg
Arm Type
Experimental
Arm Description
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
Arm Title
GC6101A 75mg
Arm Type
Experimental
Arm Description
Administer 25mg of GC6101A t.i.d for 2 weeks.
Arm Title
GC6101A 150mg
Arm Type
Experimental
Arm Description
Administer 50mg of GC6101A t.i.d for 2 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administer placebo t.i.d for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
GC6101A 37.5mg
Intervention Description
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
GC6101A 75mg
Intervention Description
Administer 25mg of GC6101A t.i.d for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
GC6101A 150mg
Intervention Description
Administer 50mg of GC6101A t.i.d for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administer placebo t.i.d for 2 weeks
Primary Outcome Measure Information:
Title
A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
Description
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]
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
A percentage of subjects showed significant improvement of stomach erosions by the endoscopy
Description
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]
Time Frame
2 weeks
Title
A percentage of subjects showed improvement of edema rating scale
Description
The definition of "improvement" is the subjects showed score changed from 2 to 1.
Time Frame
2 weeks
Title
A percentage of subjects showed improvement of erythema rating scale
Description
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Time Frame
2 weeks
Title
A percentage of subjects showed improvement of hemorrhage rating scale
Description
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Time Frame
2 weeks
Title
A percentage of subjects showed improvement of gastric symptom rating scale
Description
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Time Frame
2 weeks
Title
Adverse Events
Time Frame
2 weeks
Title
Lab results(Hematology, Blood chemistry, Urinalysis)
Time Frame
2 weeks
Title
The results of physical examinations and Vital signs(body temperature, pulse)
Time Frame
2 weeks
Title
EKG results
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Min Kim, B.S.
Phone
+82-31-260-1936
Email
dreamerkdm@greencross.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo Jin Park, MD, Ph.D
Organizational Affiliation
Yonsei University, Gangnam Severance Hospital of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University, Busan Paik Hospital of Korea
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Ryong Ji, M.D. Ph.D.
Email
tokimom@nate.com
First Name & Middle Initial & Last Name & Degree
Sam Ryong Ji, M.D. Ph.D.
Facility Name
Keimyung University, Dongsan Medical Center of Korea
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyeong Sik Park, M.D. Ph.D.
Email
seenae99@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
Gyeong Sik Park, M.D. Ph.D.
Facility Name
Wonkwang University, Hospital of Korea
City
Iksan-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok Chae Choi, M.D. Ph.D.
Email
medcsc@wonkwang.ac.kr
First Name & Middle Initial & Last Name & Degree
Seok Chae Choi, M.D. Ph.D.
Facility Name
Seoul National University, Bundang Hospital of Korea
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Yeong Kim, M.D. Ph.D.
Email
nayoungkim49@empal.com
First Name & Middle Initial & Last Name & Degree
Na Yeong Kim, M.D. Ph.D.
Facility Name
Chungang University, Hospital of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Gyu Kim, M.D. Ph.D.
Email
jgkimd@cau.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae Gyu Kim, M.D. Ph.D.
Facility Name
Ewha Womans University, Medical Center of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Kyung Jung, M.D. Ph.D.
Email
junghk@ewha.ac.kr
First Name & Middle Initial & Last Name & Degree
Hye Kyung Jung, M.D. Ph.D.
Facility Name
Inje University, Seoul Paik Hospital of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Seop Moon, M.D. Ph.D.
Email
moonjs2@unitel.co.kr
First Name & Middle Initial & Last Name & Degree
Jeong Seop Moon, M.D. Ph.D.
Facility Name
Kankbuk Samsung Medical Center of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Ho Park, M.D. Ph.D.
Email
pjho3@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jeong Ho Park, M.D. Ph.D.
Facility Name
Korea University, Guro Hospital of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Jae Park, M.D. Ph.D.
Email
gi7pjj@yahoo.co.kr
First Name & Middle Initial & Last Name & Degree
Jong Jae Park, M.D. Ph.D.
Facility Name
Seoul National University, Hospital of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Gyun Kim, M.D. Ph.D.
Email
harley1333@hanmail.net
First Name & Middle Initial & Last Name & Degree
Sang Gyun Kim, M.D. Ph.D.
Facility Name
Soonchunhyang University, Seoul Hospital of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Seong Lee, M.D. Ph.D.
Email
joonlee@schmc.ac.kr
First Name & Middle Initial & Last Name & Degree
Jun Seong Lee, M.D. Ph.D.
Facility Name
The Catholic University, Seoul St. Mary's Hospital of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Myeong Park, M.D. Ph.D.
Email
parkjerry@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae Myeong Park, M.D. Ph.D.
Facility Name
Yonsei University, Gangnam Severance Hospital of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo Jin Park, M.D. Ph.D.
Email
hjpark21@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Hyo Jin Park, M.D. Ph.D.
Facility Name
Ajou University, Medical Center of Korea
City
Suwon-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwang Jae Lee, M.D. Ph.D.
Email
kjleemd@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gwang Jae Lee, M.D. Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

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