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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353039
Recruitment Status : Unknown
Verified July 2015 by Green Cross Corporation.
Recruitment status was:  Recruiting
First Posted : February 2, 2015
Last Update Posted : July 3, 2015
Sponsor:
Collaborators:
C&R Research, Inc.
CRScube
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastritis Drug: GC6101A 37.5mg Drug: GC6101A 75mg Drug: GC6101A 150mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: GC6101A 37.5mg
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
Drug: GC6101A 37.5mg
Administer 12.5mg of GC6101A t.i.d for 2 weeks.

Experimental: GC6101A 75mg
Administer 25mg of GC6101A t.i.d for 2 weeks.
Drug: GC6101A 75mg
Administer 25mg of GC6101A t.i.d for 2 weeks.

Experimental: GC6101A 150mg
Administer 50mg of GC6101A t.i.d for 2 weeks.
Drug: GC6101A 150mg
Administer 50mg of GC6101A t.i.d for 2 weeks.

Placebo Comparator: Placebo
Administer placebo t.i.d for 2 weeks.
Drug: Placebo
Administer placebo t.i.d for 2 weeks




Primary Outcome Measures :
  1. 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]



Secondary Outcome Measures :
  1. 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]


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Adverse Events [ Time Frame: 2 weeks ]
  7. Lab results(Hematology, Blood chemistry, Urinalysis) [ Time Frame: 2 weeks ]
  8. The results of physical examinations and Vital signs(body temperature, pulse) [ Time Frame: 2 weeks ]
  9. EKG results [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353039


Contacts
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Contact: Dong-Min Kim, B.S. +82-31-260-1936 dreamerkdm@greencross.com

Locations
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Korea, Republic of
Inje University, Busan Paik Hospital of Korea Recruiting
Busan, Korea, Republic of
Contact: Sam Ryong Ji, M.D. Ph.D.       tokimom@nate.com   
Principal Investigator: Sam Ryong Ji, M.D. Ph.D.         
Keimyung University, Dongsan Medical Center of Korea Recruiting
Daegu, Korea, Republic of
Contact: Gyeong Sik Park, M.D. Ph.D.       seenae99@dsmc.or.kr   
Principal Investigator: Gyeong Sik Park, M.D. Ph.D.         
Wonkwang University, Hospital of Korea Recruiting
Iksan-si, Korea, Republic of
Contact: Seok Chae Choi, M.D. Ph.D.       medcsc@wonkwang.ac.kr   
Principal Investigator: Seok Chae Choi, M.D. Ph.D.         
Seoul National University, Bundang Hospital of Korea Recruiting
Seongnam-si, Korea, Republic of
Contact: Na Yeong Kim, M.D. Ph.D.       nayoungkim49@empal.com   
Principal Investigator: Na Yeong Kim, M.D. Ph.D.         
Chungang University, Hospital of Korea Recruiting
Seoul, Korea, Republic of
Contact: Jae Gyu Kim, M.D. Ph.D.       jgkimd@cau.ac.kr   
Principal Investigator: Jae Gyu Kim, M.D. Ph.D.         
Ewha Womans University, Medical Center of Korea Recruiting
Seoul, Korea, Republic of
Contact: Hye Kyung Jung, M.D. Ph.D.       junghk@ewha.ac.kr   
Principal Investigator: Hye Kyung Jung, M.D. Ph.D.         
Inje University, Seoul Paik Hospital of Korea Recruiting
Seoul, Korea, Republic of
Contact: Jeong Seop Moon, M.D. Ph.D.       moonjs2@unitel.co.kr   
Principal Investigator: Jeong Seop Moon, M.D. Ph.D.         
Kankbuk Samsung Medical Center of Korea Recruiting
Seoul, Korea, Republic of
Contact: Jeong Ho Park, M.D. Ph.D.       pjho3@hotmail.com   
Principal Investigator: Jeong Ho Park, M.D. Ph.D.         
Korea University, Guro Hospital of Korea Recruiting
Seoul, Korea, Republic of
Contact: Jong Jae Park, M.D. Ph.D.       gi7pjj@yahoo.co.kr   
Principal Investigator: Jong Jae Park, M.D. Ph.D.         
Seoul National University, Hospital of Korea Recruiting
Seoul, Korea, Republic of
Contact: Sang Gyun Kim, M.D. Ph.D.       harley1333@hanmail.net   
Principal Investigator: Sang Gyun Kim, M.D. Ph.D.         
Soonchunhyang University, Seoul Hospital of Korea Not yet recruiting
Seoul, Korea, Republic of
Contact: Jun Seong Lee, M.D. Ph.D.       joonlee@schmc.ac.kr   
Principal Investigator: Jun Seong Lee, M.D. Ph.D.         
The Catholic University, Seoul St. Mary's Hospital of Korea Recruiting
Seoul, Korea, Republic of
Contact: Jae Myeong Park, M.D. Ph.D.       parkjerry@catholic.ac.kr   
Principal Investigator: Jae Myeong Park, M.D. Ph.D.         
Yonsei University, Gangnam Severance Hospital of Korea Recruiting
Seoul, Korea, Republic of
Contact: Hyo Jin Park, M.D. Ph.D.       hjpark21@yuhs.ac   
Principal Investigator: Hyo Jin Park, M.D. Ph.D.         
Ajou University, Medical Center of Korea Recruiting
Suwon-si, Korea, Republic of
Contact: Gwang Jae Lee, M.D. Ph.D.       kjleemd@hotmail.com   
Principal Investigator: Gwang Jae Lee, M.D. Ph.D.         
Sponsors and Collaborators
Green Cross Corporation
C&R Research, Inc.
CRScube
Investigators
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Principal Investigator: Hyo Jin Park, MD, Ph.D Yonsei University, Gangnam Severance Hospital of Korea
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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02353039    
Other Study ID Numbers: GC6101A_P2
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases