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NCT05034952 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
A Phase 2 study of Acute Pain, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 303
- Enrollment target
- 7
- Study locations
NCT05034952: Completed Phase 2 study of Acute Pain, sponsored by Vertex Pharmaceuticals Incorporated.
NCT05034952 is a Phase 2 study of Acute Pain that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 303 participants, above the 262-participant average among 50 other Acute Pain trials with a reported enrollment target (16% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05034952, a Phase 2 study of Acute Pain, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 303 participants
- Enrollment target
- 7
- 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 an abdominoplasty.
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). SPIDr0-48 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 (7)
Texas
- First Surgical Hospital - Bellaire
- Endeavor Clinical Trials - San Antonio
Arizona
- Arizona Research Center - Phoenix
California
- Lotus Clinical Research - Pasadena
Maryland
- Chesapeake Research Group - Pasadena
Ohio
- Midwest Clinical Research Center - Dayton
Utah
- JBR Clinical Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2021-12-21 |
| Phase | Phase 2 |
What the finished NCT05034952 record still lists
NCT05034952 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, above the 262-participant average among 50 other Acute Pain trials with a reported enrollment target (16% higher).
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.
NCT05034952 lists 7 locations in 6 states (Texas, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT05034952 about?
NCT05034952 is a clinical study titled "A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty". The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.
What is the current status of trial NCT05034952?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 303 participants. The study started on 2021-08-30. Estimated completion is 2021-12-21.
What conditions does trial NCT05034952 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT05034952?
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 NCT05034952?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05034952 being conducted?
This trial has 7 study locations across Arizona, California, Maryland, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05034952's enrollment target sits among peer trials
303 10th of 50 higher than 41 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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