[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656179":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":22,"interventions":36,"overallOfficials":50,"centralContacts":13,"locations":54,"responsibleParty":79,"collaborators":13,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":13,"enrollmentInfo":92,"targetDuration":13,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":105,"overallStatus":118,"whyStopped":13,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Opioid Consumption (Total MME consumed)","Total opioid consumption (morphine milliequivalents - MME) from postoperative day (POD) 0 through POD 14, determined by returned-pill count of dispensed oxycodone.","From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"SINGLE",[21],"OUTCOMES_ASSESSOR",[23,31],{"label":24,"type":25,"description":26,"interventionNames":27},"Suzetrigine (100-50mg)","EXPERIMENTAL","Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain plus suzetrigine (100mg loading dose followed by q12 50mg PO) up to two weeks.",[28,29,30],"Drug: Suzetrigine","Drug: Acetaminophen","Drug: oxycodone",{"label":32,"type":33,"description":34,"interventionNames":35},"Standard of care","ACTIVE_COMPARATOR","Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain up to two weeks.",[29,30],[37,42,46],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"DRUG","Suzetrigine","Suzetrigine is administered at its FDA-approved dose for moderate-to-severe acute pain: a 100 mg oral loading dose followed by 50 mg orally every 12 hours. No dose modification, dose escalation, or novel route is used; the trial therefore does not involve a dosage level or route that would increase risk relative to approved labeling, which is one of the conditions supporting IND exemption under 21 CFR 312.2(b).",[24],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"Acetaminophen","Acetaminophen 1,000 mg every 6 hours (maximum 4,000 mg\u002F24 h)",[32,24],{"type":38,"name":47,"description":48,"armGroupLabels":49,"otherNames":13},"oxycodone","Oxycodone 5-10 mg every 4-6 hours",[32,24],[51],{"name":52,"affiliation":5,"role":53},"Tristan Tham, MD","PRINCIPAL_INVESTIGATOR",[55],{"facility":5,"status":13,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Palo Alto","California","94304","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-122.14302,37.44188,{"lat":65,"lon":64},[68,71,73,75,77],{"name":69,"role":70,"phone":13,"phoneExt":13,"email":13},"Pedro Martins Gomes de Oliveira, MD","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":13,"phoneExt":13,"email":13},"Uchechukwu Megwalu, MD",{"name":74,"role":70,"phone":13,"phoneExt":13,"email":13},"Robson Capasso, MD",{"name":76,"role":70,"phone":13,"phoneExt":13,"email":13},"Jonathan B Lee, MD",{"name":78,"role":70,"phone":13,"phoneExt":13,"email":13},"Sophia Chen, MD",{"type":53,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Tristan Mark Tham Yong-Ren","Assistant Professor of Otolaryngology - Head and Neck Surgery","100656179","phase-4-suzetrigine-in-tonsillectomy-for-opioid-sparing-pain-management-100656179",false,"NCT07821931","Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management","STOP Trial (Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management)","STOP","Inclusion Criteria:\n\n1. Scheduled to undergo tonsillectomy or a variant pharyngeal procedure (e.g., palatoplasty, uvulopalatopharyngoplasty \\[UPPP\\], expansion sphincter pharyngoplasty \\[ESP\\]) by a study investigator.\n2. Able to understand the consent discussion in English by telephone, provide informed consent, and comply with study procedures, including completion of electronic patient-reported outcome surveys.\n3. Willing and able to complete daily electronic (text message and\u002For email) pain surveys for 14 days and to return the dispensed opioid bottle for pill count or to respond to a telephone pill-count contact.\n\nExclusion Criteria:\n\n1. Chronic opioid use\n2. Significant hepatic disease\n3. Pregnant or breastfeeding.\n4. Known allergy or intolerance to any study medication\n5. Unable to complete patient-reported outcome measures because of language barrier, literacy, or infirmity.\n6. Current use of a strong CYP3A4 inhibitor\n7. Use of hormonal birth control and unwilling to receive suzetrigine-related counseling, given that suzetrigine may reduce hormonal contraceptive efficacy.","ALL","18 Years",{"count":93,"type":94},58,"ESTIMATED","INTERVENTIONAL",[97],"PHASE4","The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine can lower how much opioid pain medicine adults need after tonsil surgery (tonsillectomy) or a similar throat surgery.",[100,101,39,102,103,104],"Tonsillectomy","Pharyngoplasty","Opioid","Postoperative Pain","Acute Pain",[100,101,39,106,107,108,109,110,111,112,113,114,115,116,117],"Nav1.8","Postoperative pain","Acute pain","Pain","Pain, Postoperative","Analgesics, Non-Narcotic","Analgesics, Opioid","Voltage-Gated Sodium Channel Blockers","NAV1.8 Voltage-Gated Sodium Channel","Pain Management","Otorhinolaryngologic Surgical Procedures","Opioid-sparing analgesia","NOT_YET_RECRUITING","2026-09-10",{"date":121,"type":122},"2026-09-16","ACTUAL",{"date":124,"type":94},"2026-11",{"date":126,"type":94},"2027-07",{"name":5,"class":6},1]