[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100200849":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":31,"collaborators":23,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":23,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":23,"enrollmentInfo":42,"targetDuration":23,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":23,"overallStatus":51,"whyStopped":23,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":23,"leadSponsor":58,"locationsCount":23},{"fullName":5,"class":6},"Imprimis Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Impracor (Ketoprofen 10% Cream)","EXPERIMENTAL","Topical Cream over a period of 14 days",[13],"Drug: Ketoprofen 10% Cream",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo Cream:","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ketoprofen 10% Cream",null,[9],[26,27],"Impracor","IPI-110",{"type":21,"name":29,"description":23,"armGroupLabels":30,"otherNames":23},"Placebo",[15],{"type":32,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100200849","phase-3-efficacy-and-safety-of-impracor-ketoprofen-10-cream-compared-with-placebo-in-the-treatment-of-acute-pain-flare-associated-with-osteoarthritis-of-the-knee-100200849",false,"NCT01890902","Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee","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","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\u002For 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.","ALL","35 Years",{"count":43,"type":44},0,"ACTUAL","INTERVENTIONAL",[47],"PHASE3","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.",[50],"Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee","WITHDRAWN","2013-11-08",{"date":54,"type":55},"2013-11-13","ESTIMATED",{"date":57,"type":23},"2013-08",{"name":5,"class":6}]