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

NCT ID: NCT01578811

Last Updated: 2013-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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Conditions

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Erosive Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosage

SK-MS10 160mg t.i.d

Group Type EXPERIMENTAL

SK-MS10

Intervention Type DRUG

Dosage

SK-MS10 320mg t.i.d

Group Type EXPERIMENTAL

SK-MS10

Intervention Type DRUG

Dosage

Interventions

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Placebo

Dosage

Intervention Type DRUG

SK-MS10

Dosage

Intervention Type DRUG

SK-MS10

Dosage

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SKChemicals

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SK-MS10_GID_II_2010

Identifier Type: -

Identifier Source: org_study_id

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