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NCT07548385 · ClinicalTrials.gov registry record · Phase 3

Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN

A Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.

Recruiting
Registry status
Phase 3
Development phase
235
Enrollment target

NCT07548385: Recruiting Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT07548385 is a Phase 3 study that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 235 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07548385, a Phase 3 study, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.

RECRUITING
Registry status
Phase 3
Development phase
235 participants
Enrollment target

Study Summary

This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.

Primary Outcome

Total amount of opioid consumption required post-operatively.

Interventions

  • DRUG Placebo
  • DRUG Suzetrigine

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2026-04
Est. Completion 2027-02-23
Phase Phase 3

What NCT07548385 shows while recruiting

NCT07548385 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT07548385 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07548385 about?

NCT07548385 is a clinical study titled "Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN". This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrea...

What is the current status of trial NCT07548385?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2026-04. Estimated completion is 2027-02-23.

What interventions are being tested in trial NCT07548385?

The interventions under investigation include: Placebo (DRUG), Suzetrigine (DRUG).

Who is sponsoring clinical trial NCT07548385?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07548385's enrollment target sits among peer trials

235 1296th of 2000 higher than 704 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07548385, the US trial registry maintained by the National Library of Medicine. NCT07548385 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.