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Completed

NCT Number: NCT01578811

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

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

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Key information

Conditions

Erosive Gastritis

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SKChemicals

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Dosage

SK-MS10

Drug

Dosage

Primary outcomes

  1. 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 outcomes

  1. Healing rates of erosive gastritis according to the sydney classification

    Time frame: Change from Baseline in the grade of gastric erosions at 2 weeks

  2. 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

  3. Healing rates of edema according to the sydney classification

    Time frame: Change from Baseline in the grade of edema at 2 weeks

  4. Improvement rates of erythema according to the sydney classification

    Time frame: Change from Baseline in the grade of erythema at 2 weeks

  5. 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

  6. Improvement rates of symptoms using Korean NDI

    Time frame: Questionaire at baseline and then week 2

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 17, 2012
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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