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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

SK Chemicals Co.,Ltd.

ClinicalTrials.gov Identifier:

NCT01578811

First received: April 13, 2012

Last updated: March 14, 2013

Last verified: December 2010

Purpose

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

Condition	Intervention	Phase
Erosive Gastritis	Drug: Placebo Drug: SK-MS10	Phase 2

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

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:

Improvement rates of erosive gastritis according to the sydney classification [ Time Frame: Change from Baseline in the grade of erosive gastritis at 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Healing rates of erosive gastritis according to the sydney classification [ Time Frame: Change from Baseline in the grade of gastric erosions at 2 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Healing rates of edema according to the sydney classification [ Time Frame: Change from Baseline in the grade of edema at 2 weeks ] [ Designated as safety issue: No ]
Improvement rates of erythema according to the sydney classification [ Time Frame: Change from Baseline in the grade of erythema at 2 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Improvement rates of symptoms using Korean NDI [ Time Frame: Questionaire at baseline and then week 2 ] [ Designated as safety issue: No ]

Enrollment:	102
Study Start Date:	August 2011
Study Completion Date:	December 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578811

Locations

Sponsors and Collaborators

SK Chemicals Co.,Ltd.

More Information

No publications provided

Responsible Party:	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT01578811 History of Changes
Other Study ID Numbers:	SK-MS10_GID_II_2010
Study First Received:	April 13, 2012
Last Updated:	March 14, 2013
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Gastritis
Gastrointestinal Hemorrhage
Acute Disease
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Stomach Diseases
Hemorrhage
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on May 19, 2013