Clinical trial NCT02353039: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastritis
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
Collaborators: name: C&R Research, Inc.
name: CRScube
First posted: 2015-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
timeFrame: 2 weeks
Secondary outcomes:
measure: A percentage of subjects showed significant improvement of stomach erosions by the endoscopy
timeFrame: 2 weeks
measure: A percentage of subjects showed improvement of edema rating scale
timeFrame: 2 weeks
measure: A percentage of subjects showed improvement of erythema rating scale
timeFrame: 2 weeks
measure: A percentage of subjects showed improvement of hemorrhage rating scale
timeFrame: 2 weeks
measure: A percentage of subjects showed improvement of gastric symptom rating scale
timeFrame: 2 weeks
measure: Adverse Events
timeFrame: 2 weeks
measure: Lab results(Hematology, Blood chemistry, Urinalysis)
timeFrame: 2 weeks
measure: The results of physical examinations and Vital signs(body temperature, pulse)
timeFrame: 2 weeks
measure: EKG results
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University, Busan Paik Hospital of Korea
city: Daegu
country: Korea, Republic of
facility: Keimyung University, Dongsan Medical Center of Korea
city: Iksan-si
country: Korea, Republic of
facility: Wonkwang University, Hospital of Korea
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University, Bundang Hospital of Korea
city: Seoul
country: Korea, Republic of
facility: Chungang University, Hospital of Korea
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University, Medical Center of Korea
city: Seoul
country: Korea, Republic of
facility: Inje University, Seoul Paik Hospital of Korea
city: Seoul
country: Korea, Republic of
facility: Kankbuk Samsung Medical Center of Korea
city: Seoul
country: Korea, Republic of
facility: Korea University, Guro Hospital of Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University, Hospital of Korea
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University, Seoul Hospital of Korea
city: Seoul
country: Korea, Republic of
facility: The Catholic University, Seoul St. Mary's Hospital of Korea
city: Seoul
country: Korea, Republic of
facility: Yonsei University, Gangnam Severance Hospital of Korea
city: Suwon-si
country: Korea, Republic of
facility: Ajou University, Medical Center of Korea
Study officials:
affiliation: Yonsei University, Gangnam Severance Hospital of Korea
name: Hyo Jin Park, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: