Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
1 other identifier
interventional
102
1 country
1
Brief Summary
The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 13, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 18, 2013
December 1, 2010
10 months
April 13, 2012
March 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement rates of erosive gastritis according to the sydney classification
Change from Baseline in the grade of erosive gastritis at 2 weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORSK-MS10 160mg t.i.d
EXPERIMENTALSK-MS10 320mg t.i.d
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SKChemicals
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2012
First Posted
April 17, 2012
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
March 18, 2013
Record last verified: 2010-12