Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
1 other identifier
interventional
200
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 27, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 3, 2015
July 1, 2015
10 months
January 27, 2015
July 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (9)
A percentage of subjects showed significant improvement of stomach erosions by the endoscopy
2 weeks
A percentage of subjects showed improvement of edema rating scale
2 weeks
A percentage of subjects showed improvement of erythema rating scale
2 weeks
A percentage of subjects showed improvement of hemorrhage rating scale
2 weeks
A percentage of subjects showed improvement of gastric symptom rating scale
2 weeks
- +4 more secondary outcomes
Study Arms (4)
GC6101A 37.5mg
EXPERIMENTALAdminister 12.5mg of GC6101A t.i.d for 2 weeks.
GC6101A 75mg
EXPERIMENTALAdminister 25mg of GC6101A t.i.d for 2 weeks.
GC6101A 150mg
EXPERIMENTALAdminister 50mg of GC6101A t.i.d for 2 weeks.
Placebo
PLACEBO COMPARATORAdminister placebo t.i.d for 2 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Cross Corporationlead
- C&R Research, Inc.collaborator
- CRScubecollaborator
Study Sites (14)
Inje University, Busan Paik Hospital of Korea
Busan, South Korea
Keimyung University, Dongsan Medical Center of Korea
Daegu, South Korea
Wonkwang University, Hospital of Korea
Iksan-si, South Korea
Seoul National University, Bundang Hospital of Korea
Seongnam-si, South Korea
Chungang University, Hospital of Korea
Seoul, South Korea
Ewha Womans University, Medical Center of Korea
Seoul, South Korea
Inje University, Seoul Paik Hospital of Korea
Seoul, South Korea
Kankbuk Samsung Medical Center of Korea
Seoul, South Korea
Korea University, Guro Hospital of Korea
Seoul, South Korea
Seoul National University, Hospital of Korea
Seoul, South Korea
Soonchunhyang University, Seoul Hospital of Korea
Seoul, South Korea
The Catholic University, Seoul St. Mary's Hospital of Korea
Seoul, South Korea
Yonsei University, Gangnam Severance Hospital of Korea
Seoul, South Korea
Ajou University, Medical Center of Korea
Suwon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo Jin Park, MD, Ph.D
Yonsei University, Gangnam Severance Hospital of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2015
First Posted
February 2, 2015
Study Start
September 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
July 3, 2015
Record last verified: 2015-07