RCT: Suzetrigine vs Norco for Post-op Pain

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Jacob Lensing
Study ID
NCT07195669
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Pain Control

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine (SUZ) — DRUG
    Used in the course of acute post-operative pain following oral and maxillofacial surgeries
  • Norco — DRUG
    Its standard of care

Study Details

Journavx (suzetrigine) is a novel non-opioid analgesic that is FDA approved for acute pain management and may offer a promising alternative for managing postoperative pain. Suzetrigine is selective inhibitor of the sodium channel NaV1.8, for managing acute pain. NaV1.8, a sodium channel, plays a key role in transmitting pain signals. Importantly, this channel is minimally expressed in the brain, enabling effective pain control without the potential central nervous system side effects of respiratory depression and addiction associated with opioids. Clinical trials have shown Journavx to be effective in managing moderate to severe post-operative pain equal to that of opiates. This study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery. Participants in this study should be aged 18-45 without significant autoimmune diseases, chronic kidney disease, liver disease, chronic pain disorder including temporomandibular joint disorder, bleeding disorders, pregnant or nursing, undergoing either extraction of both lower third molars or orthognathic surgery of both the maxilla and mandible.

Key Dates

Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Dec 30, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suzetrigine + Ibuprofen
    \- Group 1 will receive a 100-mg oral loading dose of Journavx (suzetrigine), followed by a 50-mg maintenance dose every 12 hours (the high-dose group) and ibuprofen 800 mg q8h for 72 hours after surgery (1).
  • Active Comparator: Opioid + Ibuprofen
    \- Group 2 will receive ibuprofen 800 mg x 15 tabs q8h scheduled and hydrocodone/acetaminophen 5/325 q8h PRN for 72 hours after surgery. Patients will be informed not to exceed 3g of acetaminophen or 3200 mg ibuprofen (1).

Primary Outcome Measure

Post-operative pain [ Time Frame: 72 hours post op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
LSU Dental SchoolNew OrleansLouisiana70214
Jacob Lensing, DDS
[email protected]
641-780-0290
James Vegrzyn, DDS, MD
[email protected]
630-962-4605
Jacob Lensing, dds (PRINCIPAL_INVESTIGATOR)

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By research site
LSU Dental School· New Orleans, LA

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