Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures
NCT ID: NCT07145346
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2025-11-13
2027-08-31
Brief Summary
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Detailed Description
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Suzetrigine (Journavx) is a newly United States Food and Drug Administration (FDA)-approved, oral non-opioid analgesic that selectively inhibits the NaV1.8 voltage-gated sodium channel, which is solely expressed in peripheral nociceptive neurons. A systematic review including multiple phase III trials demonstrated suzetrigine's efficacy for pain management in both non-surgical and post-surgical patients. Suzetrigine has also been shown to have comparable analgesia to oral opioids with fewer side effects, such as nausea, vomiting, and need for rescue pain medication.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Suzetrigine arm
The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
Suzetrigine (SUZ)
The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
Control arm
The control arm will receive placebo capsules matched to suzetrigine for oral administration.
Placebo
The control arm will receive placebo capsules matched to suzetrigine for oral administration.
Interventions
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Suzetrigine (SUZ)
The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
Placebo
The control arm will receive placebo capsules matched to suzetrigine for oral administration.
Eligibility Criteria
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Inclusion Criteria
* Blunt trauma patients
* \> 3 rib fractures
* Able to tolerate oral intake
Exclusion Criteria
* Pregnant
* Prisoners
* History of adverse reaction to suzetrigine
* Current strong CYP3A inhibitor medication use
o Strong Inhibitors: clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, atazanavir, darunavir, indinavir, lopinavir, telithromycin
* Current strong or moderate CYP3A inducer
* Strong Inducers: apalutamide, carbamazepine, encorafenib, enzalutamide, fosphenytoin, lumacaftor and ivacaftor, mitotane, phenytoin, rifampin
* Moderate Inducers: bexarotene (Systemic), bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, estradiol, and norethindrone, eslicarbazepine, etravirine, fexinidazole, lorlatinib, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, phenobarbital, primidone, repotrectinib, rifabutin, rifapentine, sotorasib, St John's Wort
* Cirrhosis
* GCS \< 14
* Rhabdomyolysis (CPK \> 5,000 U/L)
* Chronic opioid use (\>30mg OME/day)
* Known or suspected active infection with human immunodeficiency virus or hepatitis B or C viruses
18 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Responsible Party
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Jeffrey Nahmias, MD
Chief, Division of Trauma, Burns and Surgical Critical Care
Locations
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University of California, Irvine
Orange, California, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffry Nahmias, MD, MHPE
Role: primary
Peter D Nguyen, MD
Role: backup
References
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Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. doi: 10.1111/j.1532-5415.2004.52223.x.
Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.
Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103.
Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.
Peng K, Zhang J, Meng XW, Liu HY, Ji FH. Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials. Pain Physician. 2017 Nov;20(7):569-596.
Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.
Gerlach AT, Murphy CV, Dasta JF. An updated focused review of dexmedetomidine in adults. Ann Pharmacother. 2009 Dec;43(12):2064-74. doi: 10.1345/aph.1M310.
Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
Other Identifiers
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7663
Identifier Type: -
Identifier Source: org_study_id