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

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

Study Overview

• Status: Completed
• Conditions: Erosive Gastritis
• Intervention / Treatment: Drug: Placebo; Drug: SK-MS10

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SKChemicals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Dosage
EXPERIMENTAL: SK-MS10 160mg t.i.d	Drug: SK-MS10; Dosage
EXPERIMENTAL: SK-MS10 320mg t.i.d	Drug: SK-MS10; Dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: April 15, 2012
• First Posted (ESTIMATE): April 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2013
• Last Update Submitted That Met QC Criteria: March 14, 2013
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: SK-MS10_GID_II_2010