A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601

Study Overview
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Brief Summary
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This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.

Detailed Description
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After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed. Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.

Official Title
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A Phase IV Clinical Trial to Evaluate the Preventive Effectiveness of NSAID-Associated Gastroduodenal Injury (Multi-center, Double-blind, Active-controlled, Stratified Randomized, Parallel Group)

Conditions
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NSAID-associated Gastroduodenal Injury

Intervention / Treatment
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* Drug: Stillen
* Drug: Cytotec (reference drug)
* Drug: NSAID (Aceclofenac)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need to take NSAID pills for longer than four weeks should be normal diagnosed by the endoscopy test Exclusion Criteria: The patients have gastric ulcer or duodenal ulcer within 30 days The patients have a gastro-intestinal surgery within a year The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stillen<br>Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID | Drug: Stillen<br> <br> Drug: NSAID (Aceclofenac)<br> <br> |
| Active Comparator: Cytotec<br>The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID | Drug: Cytotec (reference drug)<br> <br> Drug: NSAID (Aceclofenac)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of protected subjects (%) | the definition of protected is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A percentage of a protected subject (at duodenum), and of ulcer occurrence | The definition of protected is the subjects with no erosions, in other words, either zero or 1 erosion found at duodenum by the endoscopy. A percentage of ulcer occurrence | 4 weeks |