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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01578811

Enrollment

102

Registered

2012-04-17

Start date

2011-08-31

Completion date

2012-12-31

Last updated

2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Gastritis

Brief summary

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

Interventions

DRUGPlacebo

Dosage

DRUGSK-MS10

Dosage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026