Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-02-21 @ 12:57 AM
Study NCT ID:
NCT00568295
Status:
COMPLETED
Last Update Posted:
2011-08-22
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'C116926', 'term': 'rofecoxib'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2000-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-19', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.', 'timeFrame': 'Four Weeks'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the WOMAC pain subscale score', 'timeFrame': 'Weeks 1 and 2'}, {'measure': 'Change from baseline in the WOMAC stiffness and physical function subscale scores', 'timeFrame': 'Weeks 1, 2 and 4'}, {'measure': "Investigator's impression of therapeutic response", 'timeFrame': 'Weeks 1, 2, and 4'}, {'measure': "Subject's assessment of medication as an analgesic for the study knee joint", 'timeFrame': 'Weeks 1, 2, and 4'}, {'measure': 'Daily pain intensity differences from baseline', 'timeFrame': 'Week 1'}, {'measure': "Investigator's global impression of therapeutic response", 'timeFrame': 'Week 4'}, {'measure': "Subject's overall impression of the study medication", 'timeFrame': 'Week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee', 'detailedDescription': '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.\n\nAt 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.\n\nSubjects 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.\n* A history of osteoarthritis of the knee characterized by pain of at least a moderate intensity.\n* Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.\n* Subjects' physical ability was to be either American College of Rheumatology (ACR) Function Class I or II\n* At the baseline visit, subjects must have reported a maximum pain intensity experienced over the previous 24 hours of at least moderate on a five-point scale of none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be enrolled in the study.\n\nExclusion Criteria:\n\n* Medical history, physical examinations, or radiographs suggestive of other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia.\n* Medical or psychiatric conditions that may influence absorption, metabolism, or excretion of the study medications or interfere with interpretation of adverse reactions to the study drug.\n* History of allergy, sensitivity, contraindication or non-response to acetaminophen, rofecoxib, or drugs classified as NSAIDs including aspirin.\n* Use of concomitant medications that might interfere with study drug assessments, including intra-articular corticosteroids.\n* Signs of active knee inflammation, morning stiffness of greater than 30 minutes duration.\n* Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren erythrocyte sedimentation rate greater than or equal to 40 mm/hour.\n* ACR functional class III or IV, or unable to walk without assistive devices.\n* Pregnancy, lactation, or expect to become pregnant within one month of study completion."}, 'identificationModule': {'nctId': 'NCT00568295', 'briefTitle': 'A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '99-090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetaminophen', 'description': 'Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP', 'interventionNames': ['Drug: acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Refecoxib 12.5 mg', 'description': 'Rofecoxib: Capsules 12.5 mg, oral, C-904-1A', 'interventionNames': ['Drug: Rofecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rofecoxib 12.5 x 2', 'description': 'Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A', 'interventionNames': ['Drug: Rofecoxib']}], 'interventions': [{'name': 'acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': '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.', 'armGroupLabels': ['Acetaminophen']}, {'name': 'Rofecoxib', 'type': 'DRUG', 'otherNames': ['Viox'], 'description': '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.', 'armGroupLabels': ['Refecoxib 12.5 mg']}, {'name': 'Rofecoxib', 'type': 'DRUG', 'otherNames': ['Viox'], 'description': '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.', 'armGroupLabels': ['Rofecoxib 12.5 x 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Edwin Kuffner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McNeil Consumer Healthcare USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Consumer and Personal Products Worldwide', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}