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

Phase 2

Completed

• Conditions: Erosive Gastritis
• Interventions: Drug: Placebo; Drug: SK-MS10

• Registration Number: NCT01578811
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2011-08
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-15
• Study First Posted: 2012-04-17
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SK-MS10 160mg t.i.d	SK-MS10	-
SK-MS10 320mg t.i.d	SK-MS10	-

Primary Outcome Measures

Name	Time	Method
Improvement rates of erosive gastritis according to the sydney classification	Change from Baseline in the grade of erosive gastritis at 2 weeks

Secondary Outcome Measures

Name	Time	Method
Healing rates of erosive gastritis according to the sydney classification	Change from Baseline in the grade of gastric erosions at 2 weeks
Improvement rates of erosive gastritis by estimated the number of erosion	Change from Baseline in the number of gastric erosions at 2 weeks
Healing rates of edema according to the sydney classification	Change from Baseline in the grade of edema at 2 weeks
Improvement rates of erythema according to the sydney classification	Change from Baseline in the grade of erythema at 2 weeks
Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement	Change from Baseline in the grade of hemorrhage at 2 weeks
Improvement rates of symptoms using Korean NDI	Questionaire at baseline and then week 2

Trial Locations

Locations (1)

SKChemicals; 🇰🇷 Seoul, Korea, Republic of