NCT07843134

Brief Summary

This randomized clinical trial will compare suzetrigine with standard analgesia for postoperative pain management after skin cancer surgery. Adults undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck will be randomized to suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours after surgery. The study uses a double-blind, double-dummy design, and breakthrough oxycodone may be prescribed in either arm on request after same-day clinical assessment. The primary objective is to determine whether suzetrigine controls acute postoperative pain as well as scheduled acetaminophen plus ibuprofen during the first 24 hours after the first dose. Secondary outcomes include rescue opioid consumption, pain through 48 and 72 hours, satisfaction with pain control, functional recovery, adverse events, surgical bleeding, wound-healing complications, and blinding integrity.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
28mo left

Started Apr 2027

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2029

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

2.1 years

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Postoperative PainAcute PainSkin CancerCutaneous MalignancyMohs Surgery

Keywords

SuzetrigineSkin cancer surgeryCutaneous malignancyMohs micrographic surgeryStandard analgesiaIbuprofenAcetaminophen

Outcome Measures

Primary Outcomes (1)

  • Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 24 Hours

    The primary endpoint is the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10 over the first 24 hours after the first study dose, expressed as change from baseline. The endpoint will be tested for non-inferiority of suzetrigine compared with scheduled acetaminophen plus ibuprofen.

    Baseline through 24 hours after first study dose

Secondary Outcomes (12)

  • Rescue Opioid Consumption Within 24 Hours

    Baseline through 24 hours after first study dose

  • Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 48 Hours

    Baseline through 48 hours after first study dose

  • Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 72 Hours

    Baseline through 72 hours after first study dose

  • Maximum Numeric Pain Rating Scale Score

    Baseline through 72 hours after first study dose

  • Adequacy of Pain Control

    24 and 48 hours after first study dose

  • +7 more secondary outcomes

Study Arms (2)

Suzetrigine

EXPERIMENTAL

Participants randomized to this arm will receive suzetrigine monotherapy for 72 hours after Mohs micrographic surgery or wide local excision. Participants will receive a 100 mg loading dose in clinic after surgery, followed by 50 mg every 12 hours through 72 hours, with matching placebo capsules at intervening dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.

Drug: Suzetrigine

Acetaminophen Plus Ibuprofen

ACTIVE COMPARATOR

Participants randomized to this arm will receive the standard analgesic regimen of acetaminophen 1000 mg every 8 hours plus ibuprofen 400 mg every 6 hours for 72 hours after Mohs micrographic surgery or wide local excision, with matching placebo capsules at suzetrigine dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.

Drug: Acetaminophen Plus Ibuprofen

Interventions

SuzetrigineDRUG

Participants will receive suzetrigine 100 mg orally once as a loading dose in clinic after surgery, followed by suzetrigine 50 mg orally every 12 hours through 72 hours. Matching placebo capsules will be used at intervening dosing times to preserve blinding.

Also known as: JOURNAVX
Suzetrigine
Acetaminophen Plus IbuprofenDRUG

Participants will receive acetaminophen 1000 mg orally every 8 hours plus ibuprofen 400 mg orally every 6 hours through 72 hours after surgery. Matching placebo capsules will be used at suzetrigine dosing times to preserve blinding.

Also known as: Standard Analgesia
Acetaminophen Plus Ibuprofen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Biopsy-proven cutaneous malignancy of the head or neck, including melanoma, melanoma in situ, cutaneous squamous cell carcinoma, or basal cell carcinoma, or a biopsy-confirmed precursor lesion to skin cancer requiring excision
  • Planned treatment by Mohs micrographic surgery or wide local excision
  • Surgical defect requiring intermediate layered closure, complex closure, adjacent tissue transfer, or full-thickness skin graft
  • Able to take oral medications
  • Access to an electronic diary device, or willingness to use a paper backup
  • Able to provide written informed consent, with English, Hmong, or Somali language materials and interpreter support available

You may not qualify if:

  • Contraindication to ibuprofen, including active peptic ulcer disease, history of gastrointestinal bleeding, estimated glomerular filtration rate below 30 mL/min/1.73 m², or NSAID hypersensitivity
  • Moderate or severe hepatic impairment, defined as Child-Pugh Class B or C
  • Chronic heavy alcohol use
  • Known hypersensitivity to acetaminophen
  • Known hypersensitivity to opioids
  • Severe untreated obstructive sleep apnea or other respiratory compromise that would make a short course of breakthrough oxycodone unsafe
  • Concurrent use of a benzodiazepine or other sedative-hypnotic
  • Concurrent use of a strong or moderate CYP3A inhibitor, or a strong or moderate CYP3A inducer
  • Regular opioid use in the prior 30 days, meaning opioid use on most days or any standing opioid prescription
  • Body weight below 50 kg
  • Prior major bleeding on a nonsteroidal anti-inflammatory drug, or an active bleeding disorder
  • Pregnancy or breastfeeding
  • Prior adverse reaction to suzetrigine
  • Cognitive impairment precluding completion of patient-reported outcomes
  • Participation in another interventional trial within 30 days
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

M Health Fairview Clinic - Maple Grove

Maple Grove, Minnesota, 55369, United States

Location

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455, United States

Location

M Health Fairview Clinic - Wyoming

Wyoming, Minnesota, 55092, United States

Location

MeSH Terms

Conditions

Pain, PostoperativeAcute PainSkin Neoplasms

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNeoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Chandler W Rundle, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Fay

CONTACT

612-625-8625afay@umn.edu

Chandler W Rundle, MD

CONTACT

612-625-8625rundle1@umn.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck will be randomized 1:1 to suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours after surgery. The trial uses a double-blind, double-dummy, active-controlled, parallel-group design. Breakthrough oxycodone is available in both arms on request after same-day clinical assessment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

July 30, 2029

Last Updated

September 25, 2026

Record last verified: 2026-09

Locations

US(3)