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NCT05553366 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
1,075
Enrollment target

NCT05553366: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

NCT05553366 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 1,075 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05553366, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
1,075 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.

Primary Outcome

SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

Interventions

  • DRUG Placebo (matched to SUZ)
  • DRUG HB/APAP
  • DRUG Placebo (matched to HB/APAP)
  • DRUG SUZ

Trial Details

FieldValue
Enrollment Target 1,075 participants
Start Date 2022-10-03
Est. Completion 2023-12-15
Phase Phase 3
Vertex Pharmaceuticals Incorporated

191 total trials

What the finished NCT05553366 record still lists

NCT05553366 is an interventional study that assigns participants to a tested intervention. Its 1,075 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo (matched to SUZ) is the first listed.

NCT05553366 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05553366 about?

NCT05553366 is a clinical study titled "Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy". The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.

What is the current status of trial NCT05553366?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,075 participants. The study started on 2022-10-03. Estimated completion is 2023-12-15.

What interventions are being tested in trial NCT05553366?

The interventions under investigation include: Placebo (matched to SUZ) (DRUG), HB/APAP (DRUG), Placebo (matched to HB/APAP) (DRUG), SUZ (DRUG).

Who is sponsoring clinical trial NCT05553366?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05553366's enrollment target sits among peer trials

1,075 271st of 2000 higher than 1,730 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 NCT05553366, the US trial registry maintained by the National Library of Medicine. NCT05553366 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.