Study to Assess the Efficacy and Safety of SK-MS10 in Sub... | NCT01578811

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

NCT01578811

Sponsor

SK Chemicals Co., Ltd.

Status

Completed

Last Update Posted

Mar 18, 2013Estimated

Enrollment

102Actual

Phase

Phase 2

Conditions

Erosive Gastritis

Interventions

Placebo
SK-MS10
SK-MS10

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 13, 2012

First Submission Date that Met QC Criteria

Apr 15, 2012

First Posted Date

Apr 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2013

Last Update Posted Date

Mar 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
SK-MS10 160mg t.i.d	Experimental	Drug: SK-MS10
SK-MS10 320mg t.i.d	Experimental	Drug: SK-MS10

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Dosage	Placebo
SK-MS10

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement rates of erosive gastritis according to the sydney classification		Change from Baseline in the grade of erosive gastritis at 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Healing rates of erosive gastritis according to the sydney classification		Change from Baseline in the grade of gastric erosions at 2 weeks
Improvement rates of erosive gastritis by estimated the number of erosion		Change from Baseline in the number of gastric erosions at 2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided