A Phase 4 interventional study of Suzetrigine and Acetaminophen Plus Ibuprofen in Postoperative Pain, Acute Pain and Skin Cancer, sponsored by University of Minnesota. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Minnesota · Phase 4, Interventional, and Treatment
Among 18 studies testing suzetrigine in Pain, Postoperative — 17 open to participants now, 17 under way, 4 of them phase 3. suzetrigine · Pain, Postoperative.
Among the 18 studies testing suzetrigine in Pain, Postoperative, this one is the 3rd largest by planned enrollment, is one of 2 that started in 2027, is one of 14 in phase 4, reaches primary completion later than 15 of the 16 other live ones, and was the 16th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 230 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →17 of the 18 studies testing suzetrigine in Pain, Postoperative are open now, in 1 country. Each count lists the studies.
suzetrigine: first FDA approval 2025 (JOURNAVX). What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2025; this study’s year is marked. 2 started in 2027.
Median enrollment 115 across the 18 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
None of the 18 has an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 7 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
9 of the studies testing suzetrigine in Pain, Postoperative that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07539623Phase 3Icahn School of Medicine at Mount SinaiSuzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery | 2026-12-22 |
| NCT07548385Phase 3Icahn School of Medicine at Mount SinaiSuzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN | 2027-02-23 |
| NCT07839715Phase 3Vanderbilt University Medical CenterSuzetrigine Post DIEP | 2027-08 |
| NCT07355166University of California, Los AngelesSuzetrigine Versus Usual-care Opioids for Postop Pain in Sports | 2027-01 |
| NCT07821931Stanford UniversitySuzetrigine in Tonsillectomy for Opioid-sparing Pain Management | 2027-06 |
Among the 18 studies testing suzetrigine in Pain, Postoperative, from their registry updates:
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.
Postoperative pain after Mohs micrographic surgery and wide local excision is commonly managed with non-opioid analgesics, including acetaminophen and ibuprofen. However, some patients undergoing skin cancer surgery are older, medically complex, or receiving antithrombotic therapy, and postoperative analgesic choices may be limited. Suzetrigine is an FDA-approved non-opioid analgesic for moderate to severe acute pain in adults and may provide an alternative postoperative pain strategy.
This study is a prospective, randomized, double-blind, double-dummy, active-controlled, parallel-group Phase IV trial. Adults undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck requiring layered or more complex reconstruction will be enrolled at four M Health Fairview dermatologic surgery clinics in Minnesota.
Participants will be randomized 1:1 after surgery to receive either suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours. Participants in the suzetrigine arm will receive a 100 mg loading dose followed by 50 mg every 12 hours through 72 hours. Participants in the standard analgesia arm will receive acetaminophen 1000 mg every 8 hours plus ibuprofen 400 mg every 6 hours through 72 hours. Matching placebo capsules will be used so that the two regimens are identical in appearance, capsule count, and dosing schedule.
Breakthrough oxycodone 5 mg every 6 hours as needed may be prescribed in either arm if a participant reports inadequately controlled pain and is assessed by a responsible clinician. Oxycodone is prescribed through routine clinical care and is not supplied automatically as study medication.
Participants will complete electronic or paper diary assessments from baseline through Day 7, with a Day 30 safety survey and routine clinical record review through 90 days after surgery. The primary endpoint is the time-averaged area under the curve of Numeric Pain Rating Scale scores over the first 24 hours after the first dose, expressed as change from baseline, and tested for non-inferiority. Secondary outcomes include rescue opioid consumption, pain through 48 and 72 hours, patient-reported recovery and satisfaction, adverse events, wound-healing complications, surgical bleeding, and blinding integrity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Drug pages: Acetaminophen · Ibuprofen
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
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.
Time frame: Baseline through 24 hours after first study dose
Rescue Opioid Consumption Within 24 Hours
Rescue opioid consumption will be measured as total oxycodone use in morphine milligram equivalents within the first 24 hours after the first study dose.
Time frame: Baseline through 24 hours after first study dose
Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 48 Hours
Pain over 48 hours will be assessed using the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10, expressed as change from baseline.
Time frame: Baseline through 48 hours after first study dose
Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 72 Hours
Pain over the 72-hour treatment course will be assessed using the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10, expressed as change from baseline.
Time frame: Baseline through 72 hours after first study dose
Maximum Numeric Pain Rating Scale Score
Maximum postoperative pain will be assessed using the highest Numeric Pain Rating Scale score reported during the 72-hour treatment course.
Time frame: Baseline through 72 hours after first study dose
Adequacy of Pain Control
Adequacy of pain control will be assessed using participant-reported yes or no responses at 24 and 48 hours after the first study dose.
Time frame: 24 and 48 hours after first study dose
Patient Global Impression of Change
Participant-reported overall change after surgery will be assessed using the Patient Global Impression of Change at 48 hours and Day 7.
Time frame: 48 hours and Day 7 after first study dose
Satisfaction With Pain Control
Participant satisfaction with pain control will be assessed at the end of the 72-hour study medication course and at Day 7.
Time frame: 72 hours and Day 7 after first study dose
Activities of Daily Living
Functional recovery will be assessed using participant-reported activities of daily living at 24 hours and Day 7.
Time frame: 24 hours and Day 7 after first study dose
Adverse Events and Serious Adverse Events
Adverse events and serious adverse events will be collected through diary surveys, safety surveys, routine clinical care, and study safety review through Day 30.
Time frame: Baseline through Day 30 after surgery
Surgical Bleeding and Wound-Healing Complications
Surgical bleeding and wound-healing complications will be assessed using participant reports, clinical follow-up, and routine record review through 90 days after surgery.
Time frame: Baseline through 90 days after surgery
Study Drug Discontinuation Due to Adverse Events
Study drug discontinuation due to adverse events will be assessed during the 72-hour study medication course.
Time frame: Baseline through 72 hours after first study dose
Blinding Integrity
Blinding integrity will be assessed using participant, treating surgeon, and outcome assessor treatment guesses and confidence ratings. Blinding indices will be summarized descriptively.
Time frame: 72 hours and Day 7 after first study dose
Start is estimated for Apr 2027; primary completion for Apr 2029, 24 months later.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 24 months is above that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Suzetrigine