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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00392080 |
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.
Condition | Intervention | Phase |
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Osteoarthritis |
Drug: CJ-023,423 Drug: placebo Drug: naproxen |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects |
Estimated Enrollment: | 340 |
Study Start Date: | November 2006 |
Study Completion Date: | February 2008 |
Arms | Assigned Interventions |
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3: Placebo Comparator |
Drug: placebo
placebo
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1: Experimental
75 mg BID
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Drug: naproxen
naproxen
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2: Experimental |
Drug: CJ-023,423
75 mg BID
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
Anaheim, California, United States, 92801 | |
Pfizer Investigational Site | |
San Diego, California, United States, 92103-6204 | |
United States, Florida | |
Pfizer Investigational Site | |
Jupiter, Florida, United States, 33458 | |
Pfizer Investigational Site | |
South Miami, Florida, United States, 33143 | |
Pfizer Investigational Site | |
Ocoee, Florida, United States, 34761 | |
United States, New York | |
Pfizer Investigational Site | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Raleigh, North Carolina, United States, 27607 | |
Pfizer Investigational Site | |
Raleigh, North Carolina, United States, 27612 | |
United States, Texas | |
Pfizer Investigational Site | |
Houston, Texas, United States, 77074 | |
Pfizer Investigational Site | |
Houston, Texas, United States, 77090 | |
United States, Virginia | |
Pfizer Investigational Site | |
Chesapeake, Virginia, United States, 23320 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5231018 |
Study First Received: | October 23, 2006 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00392080 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Stomach Ulcer Anti-Inflammatory Agents Naproxen Osteoarthritis Ulcer Joint Diseases Cyclooxygenase Inhibitors Rheumatic Diseases |
Healthy Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Rheumatic Diseases Gout Suppressants Pharmacologic Actions |
Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |