NCT02353039

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastritis

Interventions

Type	Name	Description
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.
DRUG	Placebo	Administer placebo t.i.d for 2 weeks

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-02-02
• Last updated: 2015-07-03

Locations

14 sites across 1 country: South Korea