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

Green Cross Corporation

Status and phase: Unknown; Phase 2

Conditions: Gastritis

Treatments: Drug: Placebo; Drug: GC6101A 75mg; Drug: GC6101A 150mg; Drug: GC6101A 37.5mg

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02353039

GC6101A_P2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 4 patient groups, including a placebo group

GC6101A 37.5mg

Experimental group

Description:

Administer 12.5mg of GC6101A t.i.d for 2 weeks.

Treatment:

Drug: GC6101A 37.5mg

GC6101A 75mg

Experimental group

Description:

Administer 25mg of GC6101A t.i.d for 2 weeks.

Treatment:

Drug: GC6101A 75mg

GC6101A 150mg

Experimental group

Description:

Administer 50mg of GC6101A t.i.d for 2 weeks.

Treatment:

Drug: GC6101A 150mg

Placebo

Placebo Comparator group

Description:

Administer placebo t.i.d for 2 weeks.

Treatment:

Drug: Placebo