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

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation
• Collaborators: C&R Research, Inc.; CRScube

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