Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
NCT ID: NCT02353039
Last Updated: 2015-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2014-09-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GC6101A 37.5mg
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
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 75mg
Administer 25mg of GC6101A t.i.d for 2 weeks.
GC6101A 150mg
Administer 50mg 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.
Placebo
Administer placebo t.i.d for 2 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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C&R Research, Inc.
INDUSTRY
CRScube
UNKNOWN
Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Hyo Jin Park, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Yonsei University, Gangnam Severance Hospital of Korea
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GC6101A_P2
Identifier Type: -
Identifier Source: org_study_id
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