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Sponsored by: |
Johnson & Johnson Consumer & Personal Products Worldwide |
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Information provided by: | Johnson & Johnson Consumer & Personal Products Worldwide |
ClinicalTrials.gov Identifier: | NCT00568295 |
To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee
Condition | Intervention | Phase |
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Osteoarthritis of the Knee |
Drug: acetaminophen Drug: Rofecoxib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Four-Week Comparative Study Evaluating Acetaminophen Extended Release (3900 mg/Day) and Rofecoxib (12.5 mg/Day and 25 mg/Day)in the Treatment of Osteoarthritis of the Knee |
Enrollment: | 403 |
Study Start Date: | October 1999 |
Study Completion Date: | October 2000 |
Primary Completion Date: | October 2000 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP
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Drug: acetaminophen
Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
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2: Active Comparator
Rofecoxib: Capsules 12.5 mg, oral, C-904-1A
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Drug: Rofecoxib
Rofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
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3: Active Comparator
Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A
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Drug: Rofecoxib
Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
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An initial screening visit was performed in order to assess subject medical history and the potential eligibility of subjects. Following the initial screening visit, all potential subjects underwent a washout period from their usual arthritis medication and returned to the study center for a baseline visit to verify their eligibility.
At the completion of the baseline visit, all eligible subjects were randomly assigned to a treatment group and instructed on the dosing regimen for their assigned study medication.
Subjects returned to the study center for follow-up visits after Week 1 and Week 2 of treatment and a final visit after Week 4 of treatment or upon discontinuation from the study.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | JJCPPW ( Joyce Hauze/Clinical Documentation Administrator ) |
Study ID Numbers: | 99-090 |
Study First Received: | December 4, 2007 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00568295 |
Health Authority: | United States: Food and Drug Administration |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rofecoxib Rheumatic Diseases Acetaminophen |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Cyclooxygenase 2 Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |