Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-01 @ 3:37 AM
Study NCT ID:
NCT00488267
Status:
COMPLETED
Last Update Posted:
2012-05-30
First Post:
2007-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 679}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2012-03-14', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-17', 'studyFirstSubmitDate': '2007-06-18', 'dispFirstSubmitQcDate': '2012-05-17', 'studyFirstSubmitQcDate': '2007-06-18', 'dispFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Pain'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.', 'detailedDescription': 'The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.\n\nThe treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 through 75 years of age\n* Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.\n\nExclusion Criteria:\n\n* Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin).\n* Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs.\n* Patient has a relevant history of serious gastrointestinal disease.\n* Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.\n* Patient is taking warfarin, heparin, or low molecular weight heparin.\n* Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint).\n* Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.'}, 'identificationModule': {'nctId': 'NCT00488267', 'briefTitle': 'Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZARS Pharma Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)', 'orgStudyIdInfo': {'id': 'ZMK-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermoprofen', 'description': 'ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery \\[CHADD™\\] patch)', 'interventionNames': ['Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Matrix', 'description': 'Placebo matrix with CHADD patch.', 'interventionNames': ['Drug: Placebo Matrix/CHADD Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ketoprofen matrix/placebo CHADD', 'description': 'Ketoprofen matrix with placebo CHADD patch (no heat)', 'interventionNames': ['Drug: Ketoprofen matrix/placebo CHADD Patch']}], 'interventions': [{'name': 'ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)', 'type': 'DRUG', 'otherNames': ['Matrix Transdermal Ketoprofen CHADD System'], 'description': 'Transdermal patch applied to the knee for 12 hours daily.', 'armGroupLabels': ['Thermoprofen']}, {'name': 'Placebo Matrix/CHADD Patch', 'type': 'DRUG', 'otherNames': ['Placebo patch with heating system'], 'description': 'Transdermal patch applied to the knee for 12 hours daily.', 'armGroupLabels': ['Placebo Matrix']}, {'name': 'Ketoprofen matrix/placebo CHADD Patch', 'type': 'DRUG', 'otherNames': ['ketoprofen matrix with no heat'], 'description': 'Transdermal knee applied to the knee for 12 hours daily.', 'armGroupLabels': ['Ketoprofen matrix/placebo CHADD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': 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