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VX-548 for Acute Pain

Phase 3
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 hours
Awards & highlights

Study Summary

This trial tests a drug to see if it helps reduce pain after tummy tuck surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time-weighted sum of the Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) from 0 to 48 hours (SPID48) Compared to Placebo
Secondary outcome measures
Anemia, Sickle Cell
Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo
Proportion of Participants using Rescue Medication Compared to Placebo
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VX-548Experimental Treatment2 Interventions
Participants will receive VX-548.
Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP)Active Control2 Interventions
Participants will receive HB/APAP.
Group III: PlaceboPlacebo Group2 Interventions
Participants will receive placebos matched to VX-548 and HB/APAP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3500
Placebo (matched to HB/APAP)
2021
Completed Phase 3
~2770

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
31,269 Total Patients Enrolled
7 Trials studying Acute Pain
2,503 Patients Enrolled for Acute Pain

Media Library

VX-548 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05558410 — Phase 3
Acute Pain Research Study Groups: VX-548, Hydrocodone bitartrate/acetaminophen (HB/APAP), Placebo
Acute Pain Clinical Trial 2023: VX-548 Highlights & Side Effects. Trial Name: NCT05558410 — Phase 3
VX-548 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558410 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be a test subject for this experiment?

"This study is seeking a total of 1000 participants that currently experience acute pain and are between 18-80 years old."

Answered by AI

does VX-548 have any negative effects on patients?

"VX-548 clinical trial data has been rigorously gathered and reviewed, resulting in a Power team safety assessment of 3."

Answered by AI

Are people still being recruited to participate in this experiment?

"From what is detailed on clinicaltrials.gov, this study is still searching for participants and is currently active. The trial was first advertised on 10/10/2022 with the latest update being 11/15/2022."

Answered by AI

In how many different states is this clinical trial being conducted?

"You can find a list of the 8 locations where this clinical trial is currently accepting patients below."

Answered by AI

How many patients will be enrolled in this clinical trial?

"The sponsor, Vertex Pharmaceuticals Incorporated, needs to recruit 1000 eligible patients in order to proceed with the study. The trial will be conducted at various sites including Endeavor Clinical Trials in San Antonio, Texas and HD Research LLC | First Surgical Hospital in Bellaire, Alabama."

Answered by AI

Does this trial have an age limit, and if so, what is it?

"The age bracket for recruitment in this clinical trial are patients that are over 18 and under 80."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
2022. "Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05558410.
~447 spots leftby Apr 2025
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