Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-29 @ 2:30 AM
Study NCT ID:
NCT01890902
Status:
WITHDRAWN
Last Update Posted:
2013-11-13
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007660', 'term': 'Ketoprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-08', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-07-01', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8.', 'timeFrame': 'Day 4, 6 and 8'}], 'secondaryOutcomes': [{'measure': 'Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8.', 'timeFrame': 'Day 8'}]}, 'conditionsModule': {'conditions': ['Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen 10% Cream) compared to placebo for acute pain associated with OA flare of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of OA of the knee according to the ACR criteria.\n* Kellgren-Lawrence grade 2-3 disease\n* Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication.\n\nExclusion Criteria:\n\n* Total knee replacement surgery tentatively scheduled within next 6 months.\n* Palpable knee effusion.\n* Significant pain outside the target knee, including significant hip, back, or contralateral knee pain.\n* Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability.\n* History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia.\n* History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years.\n* Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening.\n* Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.'}, 'identificationModule': {'nctId': 'NCT01890902', 'briefTitle': 'Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imprimis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'IPI-110-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Impracor (Ketoprofen 10% Cream)', 'description': 'Topical Cream over a period of 14 days', 'interventionNames': ['Drug: Ketoprofen 10% Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Cream:', 'description': 'Topical Cream over a period of 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ketoprofen 10% Cream', 'type': 'DRUG', 'otherNames': ['Impracor', 'IPI-110'], 'armGroupLabels': ['Impracor (Ketoprofen 10% Cream)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Cream:']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imprimis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}