[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100128644":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":11,"locations":31,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":11,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"IBSA Institut Biochimique SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diclofenac HPBCD s.c. 75mg\u002Fml","EXPERIMENTAL",null,[13],"Drug: Diclofenac HPBCD s.c. 75mg\u002Fml",{"label":15,"type":16,"description":11,"interventionNames":17},"Voltarol 75mg\u002F3ml i.m.","ACTIVE_COMPARATOR",[18],"Drug: Voltarol 75mg\u002F3ml i.m.",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","1 single injection at day of dental surgical extraction",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],[27],{"name":28,"affiliation":29,"role":30},"Ian Brook, Prof","The school of Clinical Dentistry","PRINCIPAL_INVESTIGATOR",[32,43,51],{"facility":33,"status":11,"city":34,"state":11,"zip":11,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":11},"The School of Dentistry, University of Birmingham","Birmingham","United Kingdom","UK",{"type":38,"coordinates":39},"Point",[40,41],-1.89983,52.48142,{"lat":41,"lon":40},{"facility":44,"status":11,"city":45,"state":11,"zip":11,"country":35,"countryCode":36,"cosmosGeoPoint":46,"geoPoint":50,"contacts":11},"Department of oral Surgery; University Dental Hospital","Cardiff",{"type":38,"coordinates":47},[48,49],-3.18,51.48,{"lat":49,"lon":48},{"facility":52,"status":11,"city":53,"state":11,"zip":11,"country":35,"countryCode":36,"cosmosGeoPoint":54,"geoPoint":58,"contacts":11},"The School of Clinical Dentistry, The University of Sheffield","Sheffield",{"type":38,"coordinates":55},[56,57],-1.4659,53.38297,{"lat":57,"lon":56},{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100128644","phase-3-evaluation-of-the-efficacy-and-safety-of-diclofenac-hpbcd-75mgml-in-treatment-of-pain-following-dental-surgery-100128644",true,"NCT00943098","Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg\u002Fml in Treatment of Pain Following Dental Surgery","Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg\u002F1ml Injection as Compared to a Single i.m. Voltarol® 75mg\u002F3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).","Inclusion Criteria:\n\n* Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal.\n* Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery.\n* Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator.\n\nExclusion Criteria:\n\n* Surgery performed under general anaesthesia, or sedation.\n* Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator.\n* Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation.\n* Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs.\n* Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration.\n* Hepatic or renal impairment.\n* Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension.\n* Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components.\n* Patients under chronic treatment with topical or systemic analgesics\u002FNSAIDs.\n* Patients under treatment with any medication that may affect the treatment efficacy evaluation.\n* Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.",false,"ALL","18 Years","65 Years",{"count":73,"type":74},142,"ACTUAL","INTERVENTIONAL",[77],"PHASE3","The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg\u002F1ml s.c. with the marketed reference product, Voltarol® 75mg\u002F3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.",[80],"Dental Pain","COMPLETED","2012-12-17",{"date":84,"type":85},"2013-01-28","ESTIMATED",{"date":87,"type":11},"2009-09",{"date":89,"type":74},"2010-05",{"name":5,"class":6},3]