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)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Dosage
Experimental: SK-MS10 160mg t.i.d Drug: SK-MS10
Dosage
Experimental: SK-MS10 320mg t.i.d Drug: SK-MS10
Dosage

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
SKChemicals
Seoul, Korea, Republic of
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 August 20, 2014