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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
340
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Jupiter, Florida, United States
The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
Time frame: 7 days
Incidence of treatment-emergent, all-causality GI body system adverse events
Time frame: Duration of trial
Severity of Dyspepsia Assessment (SODA)
Time frame: 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.
Time frame: Duration of trial
Incidence of any gastric ulcer
Time frame: Duration of trial
Incidence of any duodenal ulcer
Time frame: Duration of trial
Incidence of any gastroduodenal erosion or ulcer
Time frame: Duration of trial
Incidence of any gastric erosion or ulcer
Time frame: Duration of trial
Incidence of any duodenal erosion or ulcer
Time frame: Duration of trial
Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer
Time frame: 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)
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Pfizer Investigational Site
Ocoee, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
...and 1 more locations
Time frame: Duration of trial
Number of gastroduodenal ulcers in each subject
Time frame: Duration of trial