Trial | NCT02353039  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    lonicera japonica ...

  • Study Participants

    200
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.
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.
Study Started
Sep 30
2014
Primary Completion
Jul 31
2015
Anticipated
Study Completion
Jul 31
2015
Anticipated
Last Update
Jul 03
2015
Estimate

Drug Placebo

Administer placebo t.i.d for 2 weeks

Drug GC6101A 37.5mg

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

Drug GC6101A 75mg

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

Drug GC6101A 150mg

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

GC6101A 37.5mg Experimental

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

GC6101A 75mg Experimental

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

GC6101A 150mg Experimental

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

Placebo Placebo Comparator

Administer placebo t.i.d for 2 weeks.

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
No Results Posted