[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657725":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":69,"studyPopulation":58,"armGroups":70,"interventions":83,"overallOfficials":95,"centralContacts":99,"locations":107,"responsibleParty":149,"collaborators":151,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":58,"eligibilityCriteria":161,"healthyVolunteers":157,"sex":162,"minAge":163,"maxAge":58,"enrollmentInfo":164,"targetDuration":58,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":177,"overallStatus":184,"whyStopped":58,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"University of Minnesota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":58},[9],{"measure":10,"description":11,"timeFrame":12},"Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 24 Hours","The primary endpoint is the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10 over the first 24 hours after the first study dose, expressed as change from baseline. The endpoint will be tested for non-inferiority of suzetrigine compared with scheduled acetaminophen plus ibuprofen.","Baseline through 24 hours after first study dose",[14,17,21,25,28,32,36,40,44,48,52,55],{"measure":15,"description":16,"timeFrame":12},"Rescue Opioid Consumption Within 24 Hours","Rescue opioid consumption will be measured as total oxycodone use in morphine milligram equivalents within the first 24 hours after the first study dose.",{"measure":18,"description":19,"timeFrame":20},"Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 48 Hours","Pain over 48 hours will be assessed using the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10, expressed as change from baseline.","Baseline through 48 hours after first study dose",{"measure":22,"description":23,"timeFrame":24},"Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 72 Hours","Pain over the 72-hour treatment course will be assessed using the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10, expressed as change from baseline.","Baseline through 72 hours after first study dose",{"measure":26,"description":27,"timeFrame":24},"Maximum Numeric Pain Rating Scale Score","Maximum postoperative pain will be assessed using the highest Numeric Pain Rating Scale score reported during the 72-hour treatment course.",{"measure":29,"description":30,"timeFrame":31},"Adequacy of Pain Control","Adequacy of pain control will be assessed using participant-reported yes or no responses at 24 and 48 hours after the first study dose.","24 and 48 hours after first study dose",{"measure":33,"description":34,"timeFrame":35},"Patient Global Impression of Change","Participant-reported overall change after surgery will be assessed using the Patient Global Impression of Change at 48 hours and Day 7.","48 hours and Day 7 after first study dose",{"measure":37,"description":38,"timeFrame":39},"Satisfaction With Pain Control","Participant satisfaction with pain control will be assessed at the end of the 72-hour study medication course and at Day 7.","72 hours and Day 7 after first study dose",{"measure":41,"description":42,"timeFrame":43},"Activities of Daily Living","Functional recovery will be assessed using participant-reported activities of daily living at 24 hours and Day 7.","24 hours and Day 7 after first study dose",{"measure":45,"description":46,"timeFrame":47},"Adverse Events and Serious Adverse Events","Adverse events and serious adverse events will be collected through diary surveys, safety surveys, routine clinical care, and study safety review through Day 30.","Baseline through Day 30 after surgery",{"measure":49,"description":50,"timeFrame":51},"Surgical Bleeding and Wound-Healing Complications","Surgical bleeding and wound-healing complications will be assessed using participant reports, clinical follow-up, and routine record review through 90 days after surgery.","Baseline through 90 days after surgery",{"measure":53,"description":54,"timeFrame":24},"Study Drug Discontinuation Due to Adverse Events","Study drug discontinuation due to adverse events will be assessed during the 72-hour study medication course.",{"measure":56,"description":57,"timeFrame":39},"Blinding Integrity","Blinding integrity will be assessed using participant, treating surgeon, and outcome assessor treatment guesses and confidence ratings. Blinding indices will be summarized descriptively.",null,{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":58,"timePerspective":58,"maskingInfo":64},"RANDOMIZED","PARALLEL","Participants undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck will be randomized 1:1 to suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours after surgery. The trial uses a double-blind, double-dummy, active-controlled, parallel-group design. Breakthrough oxycodone is available in both arms on request after same-day clinical assessment.","TREATMENT",{"masking":65,"maskingDescription":58,"whoMasked":66},"DOUBLE",[67,68],"PARTICIPANT","INVESTIGATOR","Postoperative pain after Mohs micrographic surgery and wide local excision is commonly managed with non-opioid analgesics, including acetaminophen and ibuprofen. However, some patients undergoing skin cancer surgery are older, medically complex, or receiving antithrombotic therapy, and postoperative analgesic choices may be limited. Suzetrigine is an FDA-approved non-opioid analgesic for moderate to severe acute pain in adults and may provide an alternative postoperative pain strategy.\n\nThis study is a prospective, randomized, double-blind, double-dummy, active-controlled, parallel-group Phase IV trial. Adults undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck requiring layered or more complex reconstruction will be enrolled at four M Health Fairview dermatologic surgery clinics in Minnesota.\n\nParticipants will be randomized 1:1 after surgery to receive either suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours. Participants in the suzetrigine arm will receive a 100 mg loading dose followed by 50 mg every 12 hours through 72 hours. Participants in the standard analgesia arm will receive acetaminophen 1000 mg every 8 hours plus ibuprofen 400 mg every 6 hours through 72 hours. Matching placebo capsules will be used so that the two regimens are identical in appearance, capsule count, and dosing schedule.\n\nBreakthrough oxycodone 5 mg every 6 hours as needed may be prescribed in either arm if a participant reports inadequately controlled pain and is assessed by a responsible clinician. Oxycodone is prescribed through routine clinical care and is not supplied automatically as study medication.\n\nParticipants will complete electronic or paper diary assessments from baseline through Day 7, with a Day 30 safety survey and routine clinical record review through 90 days after surgery. The primary endpoint is the time-averaged area under the curve of Numeric Pain Rating Scale scores over the first 24 hours after the first dose, expressed as change from baseline, and tested for non-inferiority. Secondary outcomes include rescue opioid consumption, pain through 48 and 72 hours, patient-reported recovery and satisfaction, adverse events, wound-healing complications, surgical bleeding, and blinding integrity.",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Suzetrigine","EXPERIMENTAL","Participants randomized to this arm will receive suzetrigine monotherapy for 72 hours after Mohs micrographic surgery or wide local excision. Participants will receive a 100 mg loading dose in clinic after surgery, followed by 50 mg every 12 hours through 72 hours, with matching placebo capsules at intervening dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.",[76],"Drug: Suzetrigine",{"label":78,"type":79,"description":80,"interventionNames":81},"Acetaminophen Plus Ibuprofen","ACTIVE_COMPARATOR","Participants randomized to this arm will receive the standard analgesic regimen of acetaminophen 1000 mg every 8 hours plus ibuprofen 400 mg every 6 hours for 72 hours after Mohs micrographic surgery or wide local excision, with matching placebo capsules at suzetrigine dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.",[82],"Drug: Acetaminophen Plus Ibuprofen",[84,90],{"type":85,"name":72,"description":86,"armGroupLabels":87,"otherNames":88},"DRUG","Participants will receive suzetrigine 100 mg orally once as a loading dose in clinic after surgery, followed by suzetrigine 50 mg orally every 12 hours through 72 hours. Matching placebo capsules will be used at intervening dosing times to preserve blinding.",[72],[89],"JOURNAVX",{"type":85,"name":78,"description":91,"armGroupLabels":92,"otherNames":93},"Participants will receive acetaminophen 1000 mg orally every 8 hours plus ibuprofen 400 mg orally every 6 hours through 72 hours after surgery. Matching placebo capsules will be used at suzetrigine dosing times to preserve blinding.",[78],[94],"Standard Analgesia",[96],{"name":97,"affiliation":5,"role":98},"Chandler W Rundle, MD","PRINCIPAL_INVESTIGATOR",[100,105],{"name":101,"role":102,"phone":103,"phoneExt":58,"email":104},"Andrew Fay","CONTACT","612-625-8625","afay@umn.edu",{"name":97,"role":102,"phone":103,"phoneExt":58,"email":106},"rundle1@umn.edu",[108,124,137],{"facility":109,"status":58,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"M Health Fairview Clinic - Maple Grove","Maple Grove","Minnesota","55369","United States","US",{"type":116,"coordinates":117},"Point",[118,119],-93.45579,45.07246,{"lat":119,"lon":118},[122,123],{"name":101,"role":102,"phone":103,"phoneExt":58,"email":104},{"name":97,"role":98,"phone":58,"phoneExt":58,"email":58},{"facility":125,"status":58,"city":126,"state":111,"zip":127,"country":113,"countryCode":114,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"M Health Fairview Clinics and Surgery Center","Minneapolis","55455",{"type":116,"coordinates":129},[130,131],-93.26384,44.97997,{"lat":131,"lon":130},[134,135],{"name":101,"role":102,"phone":103,"phoneExt":58,"email":104},{"name":136,"role":98,"phone":58,"phoneExt":58,"email":58},"Chandler Rundle, MD",{"facility":138,"status":58,"city":139,"state":111,"zip":140,"country":113,"countryCode":114,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"M Health Fairview Clinic - Wyoming","Wyoming","55092",{"type":116,"coordinates":142},[143,144],-92.99716,45.33636,{"lat":144,"lon":143},[147,148],{"name":101,"role":102,"phone":103,"phoneExt":58,"email":104},{"name":97,"role":98,"phone":58,"phoneExt":58,"email":58},{"type":150,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR",[152],{"name":153,"class":154},"Minnesota Cancer Clinical Trials Network","UNKNOWN","100657725","phase-4-suzetrigine-versus-standard-analgesia-after-skin-cancer-surgery-100657725",false,"NCT07843134","Suzetrigine Versus Standard Analgesia After Skin Cancer Surgery","Non-Opioid Postoperative Pain Management in Skin Cancer Surgery: A Randomized Trial of Suzetrigine Versus Standard Analgesia in Minnesota","Inclusion Criteria:\n\n* Age 18 years or older\n* Biopsy-proven cutaneous malignancy of the head or neck, including melanoma, melanoma in situ, cutaneous squamous cell carcinoma, or basal cell carcinoma, or a biopsy-confirmed precursor lesion to skin cancer requiring excision\n* Planned treatment by Mohs micrographic surgery or wide local excision\n* Surgical defect requiring intermediate layered closure, complex closure, adjacent tissue transfer, or full-thickness skin graft\n* Able to take oral medications\n* Access to an electronic diary device, or willingness to use a paper backup\n* Able to provide written informed consent, with English, Hmong, or Somali language materials and interpreter support available\n\nExclusion Criteria:\n\n* Contraindication to ibuprofen, including active peptic ulcer disease, history of gastrointestinal bleeding, estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m², or NSAID hypersensitivity\n* Moderate or severe hepatic impairment, defined as Child-Pugh Class B or C\n* Chronic heavy alcohol use\n* Known hypersensitivity to acetaminophen\n* Known hypersensitivity to opioids\n* Severe untreated obstructive sleep apnea or other respiratory compromise that would make a short course of breakthrough oxycodone unsafe\n* Concurrent use of a benzodiazepine or other sedative-hypnotic\n* Concurrent use of a strong or moderate CYP3A inhibitor, or a strong or moderate CYP3A inducer\n* Regular opioid use in the prior 30 days, meaning opioid use on most days or any standing opioid prescription\n* Body weight below 50 kg\n* Prior major bleeding on a nonsteroidal anti-inflammatory drug, or an active bleeding disorder\n* Pregnancy or breastfeeding\n* Prior adverse reaction to suzetrigine\n* Cognitive impairment precluding completion of patient-reported outcomes\n* Participation in another interventional trial within 30 days\n* Children\n* Fetuses\n* Neonates\n* Prisoners\n* Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent\n* Employees of the researcher\n* Students of the researcher\n* Individuals approached in emergency or acutely stressful settings","ALL","18 Years",{"count":165,"type":166},230,"ESTIMATED","INTERVENTIONAL",[169],"PHASE4","This randomized clinical trial will compare suzetrigine with standard analgesia for postoperative pain management after skin cancer surgery.\n\nAdults undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck will be randomized to suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours after surgery. The study uses a double-blind, double-dummy design, and breakthrough oxycodone may be prescribed in either arm on request after same-day clinical assessment.\n\nThe primary objective is to determine whether suzetrigine controls acute postoperative pain as well as scheduled acetaminophen plus ibuprofen during the first 24 hours after the first dose. Secondary outcomes include rescue opioid consumption, pain through 48 and 72 hours, satisfaction with pain control, functional recovery, adverse events, surgical bleeding, wound-healing complications, and blinding integrity.",[172,173,174,175,176],"Postoperative Pain","Acute Pain","Skin Cancer","Cutaneous Malignancy","Mohs Surgery",[72,178,179,180,181,182,183],"Skin cancer surgery","Cutaneous malignancy","Mohs micrographic surgery","Standard analgesia","Ibuprofen","Acetaminophen","NOT_YET_RECRUITING","2026-09-21",{"date":187,"type":188},"2026-09-25","ACTUAL",{"date":190,"type":166},"2027-04-01",{"date":192,"type":166},"2029-07-30",{"name":5,"class":6},3]