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

Gastritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02353039
• Other study ID #: GC6101A_P2
• Status: Recruiting
• Phase: Phase 2
• First received: January 27, 2015
• Last updated: July 1, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Green Cross Corporation
• Contact: Dong-Min Kim, B.S.
• Phone: +82-31-260-1936
• Email: dreamerkdm[@]greencross.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastritis

Intervention

Drug:
• GC6101A 37.5mg
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
• GC6101A 75mg
Administer 25mg of GC6101A t.i.d for 2 weeks.
• GC6101A 150mg
Administer 50mg of GC6101A t.i.d for 2 weeks.
• Placebo
Administer placebo t.i.d for 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	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	Seoul National University, Hospital of Korea	Seoul
Korea, Republic of	Soonchunhyang University, Seoul Hospital of Korea	Seoul
Korea, Republic of	The Catholic University, Seoul St. Mary's 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

Sponsors (3)

Lead Sponsor	Collaborator
Green Cross Corporation	C&R Research, Inc., CRScube

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	2 weeks	No
Secondary	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]	2 weeks	No
Secondary	A percentage of subjects showed improvement of edema rating scale	The definition of "improvement" is the subjects showed score changed from 2 to 1.	2 weeks	No
Secondary	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.	2 weeks	No
Secondary	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.	2 weeks	No
Secondary	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.	2 weeks	No
Secondary	Adverse Events		2 weeks	Yes
Secondary	Lab results(Hematology, Blood chemistry, Urinalysis)		2 weeks	Yes
Secondary	The results of physical examinations and Vital signs(body temperature, pulse)		2 weeks	Yes
Secondary	EKG results		2 weeks	Yes