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

July 1, 2015 updated by: Green Cross Corporation

Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University, Busan Paik Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Sam Ryong Ji, M.D. Ph.D.
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University, Dongsan Medical Center of Korea
        • Contact:
        • Principal Investigator:
          • Gyeong Sik Park, M.D. Ph.D.
      • Iksan-si, Korea, Republic of
        • Recruiting
        • Wonkwang University, Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Seok Chae Choi, M.D. Ph.D.
      • Seongnam-si, Korea, Republic of
        • Recruiting
        • Seoul National University, Bundang Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Na Yeong Kim, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Chungang University, Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Jae Gyu Kim, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University, Medical Center of Korea
        • Contact:
        • Principal Investigator:
          • Hye Kyung Jung, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Inje University, Seoul Paik Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Jeong Seop Moon, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Kankbuk Samsung Medical Center of Korea
        • Contact:
        • Principal Investigator:
          • Jeong Ho Park, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University, Guro Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Jong Jae Park, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University, Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Sang Gyun Kim, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Soonchunhyang University, Seoul Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Jun Seong Lee, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University, Seoul St. Mary's Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Jae Myeong Park, M.D. Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University, Gangnam Severance Hospital of Korea
        • Contact:
        • Principal Investigator:
          • Hyo Jin Park, M.D. Ph.D.
      • Suwon-si, Korea, Republic of
        • Recruiting
        • Ajou University, Medical Center of Korea
        • Contact:
        • Principal Investigator:
          • Gwang Jae Lee, M.D. Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks
Adverse Events
Time Frame: 2 weeks
2 weeks
Lab results(Hematology, Blood chemistry, Urinalysis)
Time Frame: 2 weeks
2 weeks
The results of physical examinations and Vital signs(body temperature, pulse)
Time Frame: 2 weeks
2 weeks
EKG results
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Collaborators

C&R Research, Inc.
CRScube

Investigators

  • Principal Investigator: Hyo Jin Park, MD, Ph.D, Yonsei University, Gangnam Severance Hospital of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC6101A_P2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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