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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 day 2 up to day 14
Awards & highlights
Study Summary
This trial will test a new drug to see if it can safely and effectively treat acute pain.
Who is the study for?
This trial is for adults with a BMI between 18.0 and 40.0 who are experiencing new, moderate to severe acute pain, rated ≥4 on the numeric scale. It includes both surgical patients with postoperative pain and non-surgical individuals with new pain not related to any known condition.Check my eligibility
What is being tested?
The study is testing VX-548's safety and effectiveness in treating acute pain. Participants will receive VX-548 under controlled conditions to assess how well it manages their pain symptoms.See study design
What are the potential side effects?
While specific side effects of VX-548 are not listed here, common side effects from medications treating acute pain may include nausea, dizziness, headache, or drowsiness. Individual reactions can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 2 up to day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2 up to day 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA)
Trial Design
1Treatment groups
Experimental Treatment
Group I: VX-548Experimental Treatment1 Intervention
Participants will receive VX-548 every 12 hours (q12h) up to 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3540
Find a Location
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
246 Previous Clinical Trials
32,324 Total Patients Enrolled
17 Trials studying Pain
1,024 Patients Enrolled for Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 18.0 and 40.0.If you had surgery for the same problem before, you can join only if the previous surgery was on the opposite limb or organ.If you had surgery, and you have moderate or severe pain at the surgery site, and the pain is rated 4 or higher on a scale.Your body mass index (BMI) is between 18 and 40.You have new and significant pain that is not related to a previous condition, and it is at least a 4 out of 10 on the pain scale.
Research Study Groups:
This trial has the following groups:- Group 1: VX-548
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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