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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578811
First Posted: April 17, 2012
Last Update Posted: March 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]
  • 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 ]
  • Healing rates of edema according to the sydney classification [ Time Frame: Change from Baseline in the grade of edema at 2 weeks ]
  • Improvement rates of erythema according to the sydney classification [ Time Frame: Change from Baseline in the grade of erythema at 2 weeks ]
  • 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 ]
  • Improvement rates of symptoms using Korean NDI [ Time Frame: Questionaire at baseline and then week 2 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578811


Locations
Korea, Republic of
SKChemicals
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
  More Information

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01578811     History of Changes
Other Study ID Numbers: SK-MS10_GID_II_2010
First Submitted: April 13, 2012
First Posted: April 17, 2012
Last Update Posted: March 18, 2013
Last Verified: December 2010

Additional relevant MeSH terms:
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases