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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00549549 |
This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.
Condition | Intervention | Phase |
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Arthritis, Gouty |
Drug: Indomethacin Drug: Celecoxib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Efficacy And Safety Of Celecoxib (Celebrex®) And Indomethacin In The Treatment Of Moderate To Severe Acute Gouty Arthritis |
Estimated Enrollment: | 400 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Indomethacin
indomethacin 50 mg TID for 8 days.
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2: Experimental |
Drug: Celecoxib
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg BID for 7 days.
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3: Experimental |
Drug: Celecoxib
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg BID for 7 days.
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4: Experimental |
Drug: Celecoxib
Celecoxib 50 mg BID for 8 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191219 |
Study First Received: | October 24, 2007 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00549549 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Metabolic Diseases Celecoxib Joint Diseases Cyclooxygenase Inhibitors Cardiovascular Agents Rheumatic Diseases Gout Purine-Pyrimidine Metabolism, Inborn Errors Arthritis, Gouty Metabolism, Inborn Errors |
Musculoskeletal Diseases Genetic Diseases, Inborn Analgesics, Non-Narcotic Arthritis Indomethacin Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Metabolic Disorder |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Reproductive Control Agents Gout Suppressants Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Musculoskeletal Diseases Tocolytic Agents Sensory System Agents Arthritis Therapeutic Uses Indomethacin Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Celecoxib Metabolic Diseases Joint Diseases Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Rheumatic Diseases Gout Pharmacologic Actions Arthritis, Gouty Genetic Diseases, Inborn Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |