[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723352":3,"trial-entities:NCT07723352":90,"trial-summary:NCT07723352":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":70,"locations":73,"central_contacts":83,"overall_officials":84,"references":88,"see_also_links":89},"NCT07723352","AILY2025-1283","Journavx to Treat Pain After Thumb Basal Joint Arthroplasty","A Single-Arm Open-Label Trial Evaluating the Efficacy of Suzetrigine (Journavx) in Multimodal Postoperative Pain Management Following Thumb Basal Joint Arthroplasty","ENROLLING_BY_INVITATION","2028-12-31","2026-07","2026-07-23","2026-07-21","Rothman Institute Orthopaedics","OTHER",false,"The purpose of this study is to find out how well suzetrigine, a newly FDA-approved non-opioid pain medication, works to relieve pain after thumb basal joint replacement surgery. The researchers believe that suzetrigine may provide effective pain relief during recovery without the use of opioid medications.",null,[19,20,21,22],"Thumb Basal Joint Osteoarthritis","Postoperative Pain","Joint Replacement Surgery","Joint Replacement",[],"OBSERVATIONAL",[],{"count":27,"type":28},100,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","suzetrigine 100mg","Participants will receive the recommended dosing for suzetrigine, which consists of a 100 mg oral loading dose taken in the recovery room prior to discharge, followed by 50 mg doses taken orally every 12 hours for 5 days, totaling 11 doses.",[35],"Participants undergoing thumb Basal Joint Replacement Surgery",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Acetaminophen","As part of the multimodal pain regimen, participants will also receive acetaminophen (Tylenol) (500 mg, every 4 hours, or 1000 mg, every 8 hours)",[35],[41],{"measure":42,"description":43,"timeFrame":44},"Postoperative pain","Participants Pain will be assessed using the Numeric Rating Scale (NRS)at regular daily postoperative intervals","5 days",[],"ALL","40 Years","80 Years",true,{"inclusion":51,"exclusion":56,"raw_text":69},[52,53,54,55],"Aged 40-80 years.","Undergoing thumb basal joint arthroplasty (BJA)","Able to provide informed consent.","Willing to comply with the study procedures.",[57,58,59,60,61,62,63,64,65,66,67,68],"History of substance abuse or chronic opioid use.","Known allergies to acetaminophen, oxycodone, or suzetrigine.","Severe renal or hepatic dysfunction","Estimated glomerular filtration rate less than 15 ml\u002Fmin\u002F1.73m\\^2","History of kidney transplant","Child-Pugh Class C","History of liver failure","Active hepatitis that can adversely influence hepatic function","Has had prior surgery on the study hand within the last 6 months","Is currently pregnant, planning to be pregnant, or breastfeeding","Use of strong or moderate CYP3A inhibitors or inducers, or medications known to interact with suzetrigine","Currently using a prescription pain medication other study medications","Inclusion Criteria:\n\n* Aged 40-80 years.\n* Undergoing thumb basal joint arthroplasty (BJA)\n* Able to provide informed consent.\n* Willing to comply with the study procedures.\n\nExclusion Criteria:\n\n* History of substance abuse or chronic opioid use.\n* Known allergies to acetaminophen, oxycodone, or suzetrigine.\n* Severe renal or hepatic dysfunction\n* Estimated glomerular filtration rate less than 15 ml\u002Fmin\u002F1.73m\\^2\n* History of kidney transplant\n* Child-Pugh Class C\n* History of liver failure\n* Active hepatitis that can adversely influence hepatic function\n* Has had prior surgery on the study hand within the last 6 months\n* Is currently pregnant, planning to be pregnant, or breastfeeding\n* Use of strong or moderate CYP3A inhibitors or inducers, or medications known to interact with suzetrigine\n* Currently using a prescription pain medication other study medications",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Rothman Orthopaedic Institute","Philadelphia","Pennsylvania","19107","United States",{"lat":81,"lon":82},39.95238,-75.16362,[],[85],{"name":86,"affiliation":75,"role":87},"Camilo Restrepo, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":94},[92,93],"Osteoarthrosis of the carpometacarpal joint of the thumb","Post-Operative Pain",[],{"nct_id":4,"found":49,"summary":96,"prompt_version":106},{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an observational study, meaning researchers will observe the effects of the medication. It plans to include 100 participants.","completed","Suzetrigine for Pain After Thumb Basal Joint Arthroplasty","This study is looking at how well a new, non-opioid pain medication called suzetrigine works to manage pain after thumb basal joint replacement surgery (arthroplasty). Researchers believe suzetrigine might offer good pain relief without needing opioid medications. You would receive suzetrigine and acetaminophen (Tylenol) after your surgery. The main goal is to see how much pain you have five days after surgery. This study is for people aged 40 to 80 who are having thumb basal joint replacement surgery and do not have a history of substance abuse or allergies to the study medications. The current status of this study is unclear, and it plans to enroll 100 participants.","Your pain will be measured for 5 days after surgery.",109,"You would receive a loading dose of suzetrigine in the recovery room, followed by 50 mg doses every 12 hours for 5 days. You would also take acetaminophen (Tylenol) as directed.","Not stated in the trial record.",[37],"v2"]