ClinicalTrials.gg
Not yet recruitingNCT07821931STOPUpdated Sep 16, 2026

Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management

A Phase 4 interventional study of Suzetrigine and Acetaminophen in Tonsillectomy, Pharyngoplasty and Suzetrigine, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Stanford University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies testing suzetrigine in Pain, Postoperative — 17 open to participants now, 17 under way, 4 of them phase 3. suzetrigine · Pain, Postoperative.

Planned enrollment
16th of 18
58 · median 115
Started
2026
with 14 others
Phase 4
14 of 18
13 open now
Primary completion
2027-06
later than 4 of 16 live
Registered
13th of 18
by date

Among the 18 studies testing suzetrigine in Pain, Postoperative, this one is the 16th largest by planned enrollment, is one of 15 that started in 2026, is one of 14 in phase 4, reaches primary completion later than 4 of the 16 other live ones, and was the 13th registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

Phase 4this study14 · 13 open
Phase 34 · 4 open

By the year they started

First in 2025; this study’s year is marked. 15 started in 2026.

Size and results

Median enrollment 115 across the 18 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 18 studies testing suzetrigine in Pain, Postoperative, or all of them as a file.
02

Study summary

The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine can lower how much opioid pain medicine adults need after tonsil surgery (tonsillectomy) or a similar throat surgery.

03

Conditions studied

  • Tonsillectomy
  • Pharyngoplasty
  • Suzetrigine
  • Opioid
  • Postoperative Pain
  • Acute Pain

Keywords

  • Tonsillectomy
  • Pharyngoplasty
  • Suzetrigine
  • Nav1.8
  • Postoperative pain
  • Acute pain
  • Pain
  • Pain, Postoperative
  • Analgesics, Non-Narcotic
  • Analgesics, Opioid
  • Voltage-Gated Sodium Channel Blockers
  • NAV1.8 Voltage-Gated Sodium Channel
  • Pain Management
  • Otorhinolaryngologic Surgical Procedures
  • Opioid-sparing analgesia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Scheduled to undergo tonsillectomy or a variant pharyngeal procedure (e.g., palatoplasty, uvulopalatopharyngoplasty [UPPP], expansion sphincter pharyngoplasty [ESP]) by a study investigator.
  2. Able to understand the consent discussion in English by telephone, provide , and comply with study procedures, including completion of electronic patient-reported outcome surveys.
  3. Willing and able to complete daily electronic (text message and/or email) pain surveys for 14 days and to return the dispensed opioid bottle for pill count or to respond to a telephone pill-count contact.

Exclusion criteria

Exclusion Criteria:

  1. Chronic opioid use
  2. Significant hepatic disease
  3. Pregnant or breastfeeding.
  4. Known allergy or intolerance to any study medication
  5. Unable to complete patient-reported outcome measures because of language barrier, literacy, or infirmity.
  6. Current use of a strong inhibitor
  7. Use of hormonal and unwilling to receive suzetrigine-related counseling, given that suzetrigine may reduce hormonal contraceptive efficacy.
Terms in these criteria, in plain language(3)

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.

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.

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Suzetrigine (100-50mg)

    Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain plus suzetrigine (100mg loading dose followed by q12 50mg PO) up to two weeks.

    Drug: Suzetrigine · Drug: Acetaminophen · Drug: oxycodone

  • Active comparator
    Standard of care

    Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain up to two weeks.

    Drug: Acetaminophen · Drug: oxycodone

Interventions

  • Suzetrigine is administered at its FDA-approved dose for moderate-to-severe acute pain: a 100 mg oral loading dose followed by 50 mg orally every 12 hours. No dose modification, dose escalation, or novel route is used; the trial therefore does not involve a dosage level or route that would increase risk relative to approved labeling, which is one of the conditions supporting IND exemption under 21 CFR 312.2(b).

  • Acetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h)

  • Oxycodone 5-10 mg every 4-6 hours

06

What researchers measure

Primary outcomes

  1. Opioid Consumption (Total MME consumed)

    Total opioid consumption (morphine milliequivalents - MME) from postoperative day (POD) 0 through POD 14, determined by returned-pill count of dispensed oxycodone.

    Time frame: From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively

07

Study locations

1 site
  • Stanford University
    Palo Alto, California 94304, United States
    • Pedro Martins Gomes de Oliveira, MD · Sub investigator
    • Uchechukwu Megwalu, MD · Sub investigator
    • Robson Capasso, MD · Sub investigator
    • Jonathan B Lee, MD · Sub investigator
    • Sophia Chen, MD · Sub investigator
08

References and documents

Publications

  • Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870. PubMed 37530822 ↗
  • Osteen JD, Immani S, Tapley TL, Indersmitten T, Hurst NW, Healey T, Aertgeerts K, Negulescu PA, Lechner SM. Pharmacology and Mechanism of Action of Suzetrigine, a Potent and Selective NaV1.8 Pain Signal Inhibitor for the Treatment of Moderate to Severe Pain. Pain Ther. 2025 Apr;14(2):655-674. doi: 10.1007/s40122-024-00697-0. Epub 2025 Jan 8. PubMed 39775738 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 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 7 months is below 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.

Registered
Sep 10, 2026
First posted
Sep 16, 2026
StartEst.
Nov 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jul 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07821931
Responsible party
Tristan Mark Tham Yong-Ren (Assistant Professor of Otolaryngology - Head and Neck Surgery, Stanford University) — Principal investigator
First posted
Sep 16, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Tristan Tham, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Suzetrigine

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