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Can a Non-Opioid pill ease pain after ankle replacement?

NCT ID NCT07795827

Symptom relief Sponsor: Soheil Ashkani Esfahani Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether adding suzetrigine (Journavx), a non-opioid pain medicine, to the usual pain regimen helps adults recover more comfortably after total ankle replacement. Adults aged 18 to 75 scheduled for a first-time ankle replacement can join, and all participants receive suzetrigine alongside standard care. Researchers measure pain intensity, opioid use, daily function, mood, side effects, and ankle motion at follow-up visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
suzetrigine (Journavx), an oral non-opioid pain medicine
What this could lead to
If it works, adding suzetrigine could reduce pain and opioid use after ankle replacement, pointing toward safer recovery.
What could go wrong
This is a small exploratory study with no comparison group, so results may not prove suzetrigine's benefit. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Adult patients aged 18-75 years Undergoing primary total ankle arthroplasty (TAA) Capable of completing questionnaires Capable of providing consent for enrollment Capable of using Suzetrigine times a day Capable of completing the follow-up visits Exclusion Criteria: \- BMI ≥ 50 kg/m² Pre-operative/current opioid consumption Prior history of ipsilateral ankle infection Severe hepatic impairment (Child-Pugh Class C) eGFR \< 30 ml/min Pregnant or lactating Heart failure or recent myocardial infarction Using strong CYP3A inhibitors (e.g., itraconazole) or strong/moderate CYP3A inducers (e.g., Rifampin) Women taking concomitant progestin-containing contraceptives other than levonorgestrel and norethindrone who are unwilling to use additional non-hormonal contraceptives (such as condoms) or alternative contraceptives during Suzetrigine treatment and for 28 days after discontinuation

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pain Ankle osteoarthritis Postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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