Back to resultsStudy to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
Primary Purpose
Erosive Gastritis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
SK-MS10
SK-MS10
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Gastritis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- SKChemicals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
SK-MS10 160mg t.i.d
SK-MS10 320mg t.i.d
Arm Description
Outcomes
Primary Outcome Measures
Improvement rates of erosive gastritis according to the sydney classification
Secondary Outcome Measures
Healing rates of erosive gastritis according to the sydney classification
Improvement rates of erosive gastritis by estimated the number of erosion
Healing rates of edema according to the sydney classification
Improvement rates of erythema according to the sydney classification
Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement
Improvement rates of symptoms using Korean NDI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01578811
Brief Title
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
SK-MS10 160mg t.i.d
Arm Type
Experimental
Arm Title
SK-MS10 320mg t.i.d
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage
Intervention Type
Drug
Intervention Name(s)
SK-MS10
Intervention Description
Dosage
Intervention Type
Drug
Intervention Name(s)
SK-MS10
Intervention Description
Dosage
Primary Outcome Measure Information:
Title
Improvement rates of erosive gastritis according to the sydney classification
Time Frame
Change from Baseline in the grade of erosive gastritis at 2 weeks
Secondary Outcome Measure Information:
Title
Healing rates of erosive gastritis according to the sydney classification
Time Frame
Change from Baseline in the grade of gastric erosions at 2 weeks
Title
Improvement rates of erosive gastritis by estimated the number of erosion
Time Frame
Change from Baseline in the number of gastric erosions at 2 weeks
Title
Healing rates of edema according to the sydney classification
Time Frame
Change from Baseline in the grade of edema at 2 weeks
Title
Improvement rates of erythema according to the sydney classification
Time Frame
Change from Baseline in the grade of erythema at 2 weeks
Title
Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement
Time Frame
Change from Baseline in the grade of hemorrhage at 2 weeks
Title
Improvement rates of symptoms using Korean NDI
Time Frame
Questionaire at baseline and then week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
SKChemicals
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
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