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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.
April 13, 2012
April 17, 2012
March 18, 2013
August 2011
June 2012   (Final data collection date for primary outcome measure)
Improvement rates of erosive gastritis according to the sydney classification [ Time Frame: Change from Baseline in the grade of erosive gastritis at 2 weeks ]
Improvement rates of erosive gastritis according to the sydney classfication [ Time Frame: Change from Baseline in the grade of erosive gastritis at 2 weeks ]
Complete list of historical versions of study NCT01578811 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Healing rates of erosive gastritis according to the sydney classfication [ 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 classfication [ Time Frame: Change from Baseline in the grade of edema at 2 weeks ]
  • Improvement rates of erythema according to the sydney classfication [ Time Frame: Change from Baseline in the grade of erythema at 2 weeks ]
  • Improvement rates of hemorrhage according to the scand j gastroenterol suppl [ Time Frame: Change from Baseline in the grade of hemorrhage at 2 weeks ]
  • Improvement rates of symptoms using Korean Nepean Dyspepsia Index [ Time Frame: Questionaire at baseline and then week 2 ]
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
Not Provided
The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Erosive Gastritis
  • Drug: Placebo
    Dosage
  • Drug: SK-MS10
    Dosage
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: SK-MS10 160mg t.i.d
    Intervention: Drug: SK-MS10
  • Experimental: SK-MS10 320mg t.i.d
    Intervention: Drug: SK-MS10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
December 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01578811
SK-MS10_GID_II_2010
Yes
Not Provided
Not Provided
SK Chemicals Co.,Ltd.
SK Chemicals Co.,Ltd.
Not Provided
Not Provided
SK Chemicals Co.,Ltd.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP