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

Erosive Gastritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578811
• Other study ID #: SK-MS10_GID_II_2010
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2012
• Last updated: March 14, 2013
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2010
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erosive Gastritis
• Gastritis

Intervention

Drug:
• Placebo
Dosage
• SK-MS10
Dosage
• SK-MS10
Dosage

Locations

Country	Name	City	State
Korea, Republic of	SKChemicals	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement rates of erosive gastritis according to the sydney classification		Change from Baseline in the grade of erosive gastritis at 2 weeks	No
Secondary	Healing rates of erosive gastritis according to the sydney classification		Change from Baseline in the grade of gastric erosions at 2 weeks	No
Secondary	Improvement rates of erosive gastritis by estimated the number of erosion		Change from Baseline in the number of gastric erosions at 2 weeks	No
Secondary	Healing rates of edema according to the sydney classification		Change from Baseline in the grade of edema at 2 weeks	No
Secondary	Improvement rates of erythema according to the sydney classification		Change from Baseline in the grade of erythema at 2 weeks	No
Secondary	Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement		Change from Baseline in the grade of hemorrhage at 2 weeks	No
Secondary	Improvement rates of symptoms using Korean NDI		Questionaire at baseline and then week 2	No