A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

Study Overview
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Brief Summary
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CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.

Official Title
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A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: CJ-023,423
* Drug: placebo
* Drug: naproxen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug; Exclusion Criteria: Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0); Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3<br> | Drug: placebo<br>* placebo<br>|
| Experimental: 1<br>75 mg BID | Drug: naproxen<br>* naproxen<br>|
| Experimental: 2<br> | Drug: CJ-023,423<br>* 75 mg BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent, all-causality GI body system adverse events |  | Duration of trial | 
| Severity of Dyspepsia Assessment (SODA) |  | Duration of trial | 
| Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores. |  | Duration of trial | 
| Incidence of any gastric ulcer |  | Duration of trial | 
| Incidence of any duodenal ulcer |  | Duration of trial | 
| Incidence of any gastroduodenal erosion or ulcer |  | Duration of trial | 
| Incidence of any gastric erosion or ulcer |  | Duration of trial | 
| Incidence of any duodenal erosion or ulcer |  | Duration of trial | 
| Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer |  | Duration of trial | 
| Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D) |  | Duration of trial | 
| Number of gastroduodenal ulcers in each subject |  | Duration of trial |