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Rib FracturesPhase 4NCT07145346

Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures

A Phase 4 study testing Suzetrigine (SUZ) in people with Rib Fractures, run by University of California, Irvine at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Rib fractures cause a significant amount of pain and are associated with an increased risk of lung infections, long hospitalization, and increased cost. Effective pain control is the cornerstone of management to improve lung function and minimize complications. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rib Fractures
What is being tested?
Suzetrigine (SUZ)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
13 Nov 2025to Aug 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 18 years old
  • Blunt trauma patients
  • > 3 rib fractures
  • Able to tolerate oral intake

Who cannot join

  • < 17 years old
  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of California, Irvine

    Orange, California, 92868

Other trials in United States

About this study

Official title: Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures: A Randomized Controlled Trial

Rib fractures cause a significant amount of pain and are associated with an increased risk of lung infections, long hospitalization, and increased cost. Effective pain control is the cornerstone of management to improve lung function and minimize complications. Most often this is done with a multimodal pain routine consisting of: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), topical lidocaine, muscle relaxants, and opioids. However, suzetrigine is a promising alternative to treat acute pain associated with rib fractures. We think the addition of suzetrigine to a multimodal pain regimen will improve pain and decrease opioid use.

Read the detailed description

Rib fractures are a common and painful injury associated with increased risk of pneumonia, prolonged hospitalization, and higher healthcare utilization. In a national database review, rib fractures were associated with a 10% mortality rate, with mortality increasing incrementally with each additional rib fractured. Effective analgesia is essential in management of these injuries, as improved pain control optimizes pulmonary mechanics and reduces complications. Current analgesic strategies include multimodal pain regimens consisting of oral and transdermal analgesics or regional anesthetics such as epidural catheters. Historically, opioids have been a major component of analgesia, however they are highly addictive and can lead to respiratory depression and epidurals are invasive procedures with associated risks.

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
Rib Fractures
Being tested
Suzetrigine (SUZ), Placebo
Keywords
blunt chest trauma, rib fractures, Suzetrigine, multimodal pain regimen
Medical subject headings
Rib Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suzetrigine (SUZ)Drug

    The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).

  • PlaceboDrug

    The control arm will receive placebo capsules matched to suzetrigine for oral administration.

Study groups in NCT07145346
Study groupRoleWhat they receive
Suzetrigine armExperimentalThe intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
Receives: Drug: Suzetrigine (SUZ)
Control armPlacebo comparatorThe control arm will receive placebo capsules matched to suzetrigine for oral administration.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Pain

    Pain will be measured on a numerical pain scale from 0 (no pain) to 10 (most pain). Higher pain scores equate to worse outcomes.

    Measured: Through study completion of index hospitalization (up to 2 years)

  2. Use of morphine and morphine equivalents

    Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients.

    Measured: Through study completion of index hospitalization (up to 2 years)

Secondary outcomes (4)

  1. Epidural Administration

    Epidural use - patients that fail pain management will be offered an epidural

    Measured: Through study completion of index hospitalization (up to 2 years)

  2. Time in the Hospital

    ICU length of stay - number of days in the ICU Hospital length of stay - number of days admitted to the acute care hospital

    Measured: Through study completion of index hospitalization (up to 2 years)

  3. Respiratory Complications

    Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry

    Measured: Through study completion of index hospitalization (up to 2 years)

  4. Mortality

    Mortality - in-hospital mortality rate and 30-day mortality

    Measured: Through study completion of index hospitalization (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start13 Nov 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, double-blinded, placebo-controlled trial
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07145346
Sponsor's protocol ID
7663
Status last verified
Dec 2025
First submitted
14 Aug 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27533913

  • 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.

    PubMed 15086666

  • 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.

    PubMed 10866248

  • 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.

    PubMed 30376537

  • 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.

    PubMed 23706726

  • 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.

    PubMed 29149140

  • 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.

    PubMed 27812971

  • 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.

    PubMed 19934395

  • 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.

    PubMed 16269301

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Suzetrigine (SUZ) in people with Rib Fractures, run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Pain (time frame: Through study completion of index hospitalization (up to 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07145346, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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