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NCT04977336 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
A Phase 2 study of Acute Pain, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 274
- Enrollment target
- 12
- Study locations
NCT04977336: Completed Phase 2 study of Acute Pain, sponsored by Vertex Pharmaceuticals Incorporated.
NCT04977336 is a Phase 2 study of Acute Pain that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 274 participants, roughly in line with the 263-participant average among 50 other Acute Pain trials with a reported enrollment target. The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04977336, a Phase 2 study of Acute Pain, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 274 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating 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 by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (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).
Conditions Studied
Interventions
- DRUG VX-548
- DRUG HB/APAP
- DRUG Placebo (matched to VX-548)
- DRUG Placebo (matched to HB/APAP)
Study Locations (12)
California
- Anaheim Clinical Trials - Anaheim
- Lotus Clinical Research - Pasadena
- New Hope Research Development - Tarzana
Texas
- First Surgical Hospital - Bellaire
- Legent Orthopedic Hospital - Carrollton
- Endeavor Clinical Trials - San Antonio
Alabama
- Shoals Medical Trials Inc. - Sheffield
Arizona
- Arizona Research Center - Phoenix
Georgia
- Atlanta Center for Medical Research - Atlanta
Maryland
- Chesapeake Research Group - Pasadena
Ohio
- Midwest Clinical Research Center - Dayton
Utah
- JBR Clinical Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2021-07-19 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 2 |
What the finished NCT04977336 record still lists
NCT04977336 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 263-participant average among 50 other Acute Pain trials with a reported enrollment target.
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 4 interventions - of which VX-548 is the first listed.
NCT04977336 lists 12 locations in 8 states (California, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT04977336 about?
NCT04977336 is a clinical study titled "A Study Evaluating 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 VX-548 doses in treating acute pain after a bunionectomy.
What is the current status of trial NCT04977336?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 274 participants. The study started on 2021-07-19. Estimated completion is 2022-03-04.
What conditions does trial NCT04977336 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT04977336?
The interventions under investigation include: VX-548 (DRUG), HB/APAP (DRUG), Placebo (matched to VX-548) (DRUG), Placebo (matched to HB/APAP) (DRUG).
Who is sponsoring clinical trial NCT04977336?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04977336 being conducted?
This trial has 12 study locations across Alabama, Arizona, California, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04977336's enrollment target sits among peer trials
274 12th of 50 higher than 39 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain 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.
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