Status:
COMPLETED
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00392080
Start Date
November 1 2006
End Date
February 1 2008
Last Update
March 24 2008
Active Locations (11)
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1
Pfizer Investigational Site
Anaheim, California, United States, 92801
2
Pfizer Investigational Site
San Diego, California, United States, 92103-6204
3
Pfizer Investigational Site
Jupiter, Florida, United States, 33458
4
Pfizer Investigational Site
Ocoee, Florida, United States, 34761