TonsillectomyPhase 4STOPNCT07821931
Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management
A Phase 4 study testing Suzetrigine, Acetaminophen and oxycodone in people with Tonsillectomy and Pharyngoplasty, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsillectomy, Pharyngoplasty, Suzetrigine
- What is being tested?
- Suzetrigine, Acetaminophen and oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 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
- Scheduled to undergo tonsillectomy or a variant pharyngeal procedure (e.g., palatoplasty, uvulopalatopharyngoplasty [UPPP], expansion sphincter pharyngoplasty [ESP]) by a study investigator.
- Able to understand the consent discussion in English by telephone, provide informed consent, and comply with study procedures, including completion of electronic patient-reported outcome surveys.
- 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.
Who cannot join
- Chronic opioid use
- Significant hepatic disease
- Pregnant or breastfeeding.
- Known allergy or intolerance to any study medication
- Unable to complete patient-reported outcome measures because of language barrier, literacy, or infirmity.
- Current use of a strong CYP3A4 inhibitor
- Use of hormonal birth control and unwilling to receive suzetrigine-related counseling, given that suzetrigine may reduce hormonal contraceptive efficacy.
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
Stanford University
Palo Alto, California, 94304
Pedro Martins Gomes de Oliveira, MD
Uchechukwu Megwalu, MD
About this study
Official title: STOP Trial (Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management)
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.
- Conditions
- Tonsillectomy, Pharyngoplasty, Suzetrigine, Opioid, Postoperative Pain, Acute Pain
- Being tested
- Suzetrigine, Acetaminophen, oxycodone
- 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
- Medical subject headings
- Pain, Postoperative, Acute Pain, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
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).
AcetaminophenDrug
Acetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h)
oxycodoneDrug
Oxycodone 5-10 mg every 4-6 hours
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine (100-50mg) | Experimental | 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. Receives: Drug: Suzetrigine; Drug: Acetaminophen; Drug: oxycodone |
| Standard of care | Active comparator | Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain up to two weeks. Receives: Drug: Acetaminophen; Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tristan Mark Tham Yong-Ren, Stanford University
- Investigators
- Tristan Tham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821931
- Sponsor's protocol ID
- 88536
- Acronym
- STOP
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 37530822Osteen 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP Trial (Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management)
- ClinicalTrials.gov ID
- NCT07821931
- Acronym / sponsor ID
- STOP / 88536
- Conditions
- Tonsillectomy, Pharyngoplasty, Suzetrigine, Opioid, Postoperative Pain, Acute Pain
- Keywords
- Tonsillectomy, Pharyngoplasty, Suzetrigine, Nav1.8, Postoperative pain, Acute pain, Pain, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine (100-50mg) | Experimental | Drug: Suzetrigine, Drug: Acetaminophen, Drug: oxycodoneParticipants 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. |
| Standard of care | Active comparator | Drug: Acetaminophen, Drug: oxycodoneParticipants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain up to two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo tonsillectomy or a variant pharyngeal procedure (e.g., palatoplasty, uvulopalatopharyngoplasty [UPPP], expansion sphincter pharyngoplasty [ESP]) by a study investigator.
- Able to understand the consent discussion in English by telephone, provide informed consent, and comply with study procedures, including completion of electronic patient-reported outcome surveys.
- 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.
Key exclusion criteria (7 listed)
- Chronic opioid use
- Significant hepatic disease
- Pregnant or breastfeeding.
- Known allergy or intolerance to any study medication
- Unable to complete patient-reported outcome measures because of language barrier, literacy, or infirmity.
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 |
|---|---|---|
| SuzetrigineSuzetrigine 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). | Drug | Suzetrigine (100-50mg) |
| AcetaminophenAcetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h) | Drug | Standard of care, Suzetrigine (100-50mg) |
| oxycodoneOxycodone 5-10 mg every 4-6 hours | Drug | Standard of care, Suzetrigine (100-50mg) |
Primary outcome
Opioid Consumption (Total MME consumed)
Time frame: From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively
Total opioid consumption (morphine milliequivalents - MME) from postoperative day (POD) 0 through POD 14, determined by returned-pill count of dispensed oxycodone.
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 16 Sep 2026.
- Background: PubMed 37530822Jones 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.
- Background: PubMed 39775738Osteen 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.
- Individual participant dataSharing planned: Yes
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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.
Tristan Tham, MD principal investigator
Stanford University
1 site 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, Acetaminophen and oxycodone in people with Tonsillectomy and Pharyngoplasty, run by Stanford University 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 3 inclusion and 7 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 16 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 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. 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?
Opioid Consumption (Total MME consumed) (time frame: From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively). 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 NCT07821931, which also lists 2 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 16 Sep 2026.