Postoperative PainPhase 4NCT07843134
Suzetrigine Versus Standard Analgesia After Skin Cancer Surgery
A Phase 4 study testing Suzetrigine and Acetaminophen Plus Ibuprofen in people with Postoperative Pain and Acute Pain, run by University of Minnesota at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Acute Pain, Skin Cancer
- What is being tested?
- Suzetrigine and Acetaminophen Plus Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2027to 30 Jul 2029
- 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
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Children
- Fetuses
- Neonates
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Employees of the researcher
- Students of the researcher
- Individuals approached in emergency or acutely stressful settings
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
M Health Fairview Clinic - Maple Grove
Maple Grove, Minnesota, 55369
Andrew Fay, 612-625-8625, afay@umn.edu
Chandler W Rundle, MD
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455
Andrew Fay, 612-625-8625, afay@umn.edu
Chandler Rundle, MD
M Health Fairview Clinic - Wyoming
Wyoming, Minnesota, 55092
Andrew Fay, 612-625-8625, afay@umn.edu
Chandler W Rundle, MD
About this study
Official title: Non-Opioid Postoperative Pain Management in Skin Cancer Surgery: A Randomized Trial of Suzetrigine Versus Standard Analgesia in Minnesota
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.
Read the detailed description
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.
- Conditions
- Postoperative Pain, Acute Pain, Skin Cancer, Cutaneous Malignancy, Mohs Surgery
- Being tested
- Suzetrigine, Acetaminophen Plus Ibuprofen
- Keywords
- Suzetrigine, Skin cancer surgery, Cutaneous malignancy, Mohs micrographic surgery, Standard analgesia, Ibuprofen, Acetaminophen
- Medical subject headings
- Pain, Postoperative, Acute Pain, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Also called JOURNAVX
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.
Acetaminophen Plus IbuprofenDrug
Also called Standard Analgesia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Acetaminophen Plus Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 24 hours after first study dose
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72 hours and Day 7 after first study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Cancer Clinical Trials Network
- Responsible party
- Sponsor
- Investigators
- Chandler W Rundle, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843134
- Sponsor's protocol ID
- Suzetrigine-SkinCancer-2026
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Opioid Postoperative Pain Management in Skin Cancer Surgery: A Randomized Trial of Suzetrigine Versus Standard Analgesia in Minnesota
- ClinicalTrials.gov ID
- NCT07843134
- Acronym / sponsor ID
- Suzetrigine-SkinCancer-2026
- Conditions
- Postoperative Pain, Acute Pain, Skin Cancer, Cutaneous Malignancy, Mohs Surgery
- Keywords
- Suzetrigine, Skin cancer surgery, Cutaneous malignancy, Mohs micrographic surgery, Standard analgesia, Ibuprofen, Acetaminophen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Cancer Clinical Trials Network
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine | Experimental | Drug: SuzetrigineParticipants 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. |
| Acetaminophen Plus Ibuprofen | Active comparator | Drug: Acetaminophen Plus IbuprofenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuzetrigineAlso: JOURNAVXParticipants 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. | Drug | Suzetrigine |
| Acetaminophen Plus IbuprofenAlso: Standard AnalgesiaParticipants 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. | Drug | Acetaminophen Plus Ibuprofen |
Primary outcome
Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 24 Hours
Time frame: Baseline through 24 hours after first study dose
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.
12 secondary outcomes
Rescue Opioid Consumption Within 24 Hours
Time frame: Baseline through 24 hours after first study dose
Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 48 Hours
Time frame: Baseline through 48 hours after first study dose
Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 72 Hours
Time frame: Baseline through 72 hours after first study dose
Maximum Numeric Pain Rating Scale Score
Time frame: Baseline through 72 hours after first study dose
Adequacy of Pain Control
Time frame: 24 and 48 hours after first study dose
Patient Global Impression of Change
Time frame: 48 hours and Day 7 after first study dose
Satisfaction With Pain Control
Time frame: 72 hours and Day 7 after first study dose
Activities of Daily Living
Time frame: 24 hours and Day 7 after first study dose
Adverse Events and Serious Adverse Events
Time frame: Baseline through Day 30 after surgery
Surgical Bleeding and Wound-Healing Complications
Time frame: Baseline through 90 days after surgery
Study Drug Discontinuation Due to Adverse Events
Time frame: Baseline through 72 hours after first study dose
Blinding Integrity
Time frame: 72 hours and Day 7 after first study dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chandler W Rundle, MD principal investigator
University of Minnesota
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suzetrigine and Acetaminophen Plus Ibuprofen in people with Postoperative Pain and Acute Pain, run by University of Minnesota at 3 sites 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 7 inclusion and 23 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Contact Andrew Fay (612-625-8625, afay@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 24 Hours (time frame: Baseline through 24 hours after first study dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.