[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630655":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":33,"studyPopulation":21,"armGroups":34,"interventions":46,"overallOfficials":54,"centralContacts":59,"locations":65,"responsibleParty":81,"collaborators":21,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":21,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":21,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":107,"whyStopped":21,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Cali Pharmaceuticals LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative Pain with activity","AUC NRS-A wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain with Activity where 0 is no pain and 10 is worst pain imaginable)","24 hours",[14,18],{"measure":15,"description":16,"timeFrame":17},"Postoperative Pain with rest","AUC NRS-R wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain at Rest where 0 is no pain and 10 is worst pain imaginable)","24 hours, 72 hours",{"measure":19,"description":20,"timeFrame":17},"Postoperative rescue medication use","Opioid and non-opioid pain control medicines needed",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Bunionectomy","TREATMENT",{"masking":28,"maskingDescription":21,"whoMasked":29},"TRIPLE",[30,31,32],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"CPL-01","EXPERIMENTAL","Intra-operative local administration",[40],"Drug: CPL-01",{"label":42,"type":43,"description":38,"interventionNames":44},"Saline placebo","PLACEBO_COMPARATOR",[45],"Drug: saline placebo",[47,51],{"type":48,"name":36,"description":49,"armGroupLabels":50,"otherNames":21},"DRUG","Administration by the Surgeon during the operation",[36],{"type":48,"name":52,"description":49,"armGroupLabels":53,"otherNames":21},"saline placebo",[42],[55],{"name":56,"affiliation":57,"role":58},"Todd Bertoch, MD","CenExel","PRINCIPAL_INVESTIGATOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":21,"email":64},"Erol Onel, MD","CONTACT","203-837-6500","e.onel@calibiosciences.com",[66],{"facility":57,"status":21,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Salt Lake City","Utah","84107","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-111.89105,40.76078,{"lat":76,"lon":75},[79],{"name":56,"role":62,"phone":80,"phoneExt":21,"email":64},"801-261-2000",{"type":82,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100630655","phase-3-phase-3-bunionectomy-study-100630655",false,"NCT07490496","Phase 3 Bunionectomy Study","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy","Inclusion Criteria:\n\n* Bunion\n\nExclusion Criteria:\n\n* Concomitant conditions","ALL","18 Years","75 Years",{"count":94,"type":95},112,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.",[101,102],"Postoperative Pain","Bunion",[104,105,106],"bunionectomy","bunion","osteotomy","NOT_YET_RECRUITING","2026-03-23",{"date":110,"type":111},"2026-03-27","ACTUAL",{"date":113,"type":95},"2026-07-01",{"date":115,"type":95},"2026-11-28",{"name":5,"class":6},1]