CompletedPhase 2

Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis

South Korea102 participantsStarted 2011-08

Plain-language summary

The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.

Age range19 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment.
✓. Patients who voluntarily signed written informed consent may participate in the study.

✕. Pregnant or lactating female.
✕. Patients have gastric ulcer, duodenal ulcer and GERD.
✕. Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy
✕. Patients requiring corticosteroid therapy
✕. Severe neurological or psychological disease
✕. History of allergic reaction to the medications used in this study
✕. Use of other investigational drugs within 30 days prior to the study.
✕. Patients that investigators consider ineligible for this study

Improvement rates of erosive gastritis according to the sydney classification

Timeframe: Change from Baseline in the grade of erosive gastritis at 2 weeks

NCT IDNCT01578811

SponsorSK Chemicals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-06