[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100128595":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":40,"centralContacts":11,"locations":45,"responsibleParty":102,"collaborators":11,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":11,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":11,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":11,"overallStatus":124,"whyStopped":11,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"IBSA Institut Biochimique SA","INDUSTRY",[8,14,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Diclofenac HPBCD s.c. 25mg\u002Fml","EXPERIMENTAL",null,[13],"Drug: Diclofenac HPBCD",{"label":15,"type":10,"description":11,"interventionNames":16},"Diclofenac HPBCD s.c. 50mg\u002Fml",[13],{"label":18,"type":19,"description":11,"interventionNames":20},"Diclofenac HPBCD s.c. 75mg\u002Fml","ACTIVE_COMPARATOR",[13],{"label":22,"type":23,"description":11,"interventionNames":24},"Placebo s.c. (1ml)","PLACEBO_COMPARATOR",[25],"Other: Placebo s.c.",[27,32,34,36],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","Diclofenac HPBCD","1 single injection at day of dental surgical extraction",[9],{"type":28,"name":29,"description":30,"armGroupLabels":33,"otherNames":11},[15],{"type":28,"name":29,"description":30,"armGroupLabels":35,"otherNames":11},[18],{"type":37,"name":38,"description":30,"armGroupLabels":39,"otherNames":11},"OTHER","Placebo s.c.",[22],[41],{"name":42,"affiliation":43,"role":44},"Thomas Dietrich, Prof","The school of dentistry, University of Birmingham","PRINCIPAL_INVESTIGATOR",[46,58,67,73,82,93],{"facility":47,"status":11,"city":48,"state":11,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":11},"Gabinet Stomatologiczny Bartek","Kobyłka","05-230","Poland","PL",{"type":53,"coordinates":54},"Point",[55,56],21.19589,52.33953,{"lat":56,"lon":55},{"facility":59,"status":11,"city":60,"state":11,"zip":61,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":66,"contacts":11},"Centrum Leczenia Chorób Cywilizacyjnych","Warsaw","02-797",{"type":53,"coordinates":63},[64,65],21.01178,52.22977,{"lat":65,"lon":64},{"facility":68,"status":11,"city":60,"state":11,"zip":69,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":72,"contacts":11},"Niepubliczny Zakład Opieki Zdrowotnej","03-252",{"type":53,"coordinates":71},[64,65],{"lat":65,"lon":64},{"facility":74,"status":11,"city":75,"state":11,"zip":76,"country":50,"countryCode":51,"cosmosGeoPoint":77,"geoPoint":81,"contacts":11},"NZOZ Polimedica","Zgierz","95-100",{"type":53,"coordinates":78},[79,80],19.40623,51.85561,{"lat":80,"lon":79},{"facility":83,"status":11,"city":84,"state":11,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":11},"The School of Dentistry; University of Birmingham","Birmingham","B4 6NN","United Kingdom","UK",{"type":53,"coordinates":89},[90,91],-1.89983,52.48142,{"lat":91,"lon":90},{"facility":94,"status":11,"city":95,"state":11,"zip":96,"country":86,"countryCode":87,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"Eastman Dental Institute, University College London","London","WC1X8LD",{"type":53,"coordinates":98},[99,100],-0.12574,51.50853,{"lat":100,"lon":99},{"type":103,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100128595","phase-3-evaluation-of-the-efficacy-and-safety-of-diclofenac-hpbcd-25-50-mgml-in-the-treatment-of-post-surgical-pain-following-dental-surgery-100128595",true,"NCT00942448","Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg\u002Fml in the Treatment of Post-surgical Pain Following Dental Surgery","Efficacy and Safety Study of Diclofenac HPBCD 25, 50 mg\u002Fml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction)","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":116,"type":117},306,"ACTUAL","INTERVENTIONAL",[120],"PHASE3","The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg\u002F1 ml and 50 mg\u002F1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.",[123],"Dental Pain","COMPLETED","2012-12-17",{"date":127,"type":128},"2013-01-28","ESTIMATED",{"date":130,"type":11},"2009-09",{"date":132,"type":117},"2010-04",{"name":5,"class":6},6]