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NCT05553366 (VX-548 HB/APAP in Acute Pain After a Bunionectomy): BVCT ex-ante prediction vs. reported outcome

On 12 Oct 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 30 Jan 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and overall commercially sufficient.

Clinical Trial

NCTID
NCT05553366
Drug Name
VX-548 HB/APAP
Drug MoA
NaV1.8 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Acute Pain After a Bunionectomy
Human Patients
1075
Sponsor
Vertex Pharmaceuticals
Phase
Phase 3

Prediction of , index 1285

Prospective Prediction
Prediction Index
1285
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit due to superior-to-HB/APAP efficacy and non-inferior-to-HB/APAP toxicity)
Technical Prediction
SUCCESS (statistically significant clinical benefit compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
110 days in advance
Readout Data Interpretation
statistically significant than placebo; VX-548 is superior to HB/APAP in SPID48 for bunionectomy (P=0.0016) and non-superior in other endpoints.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and overall commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Phase
Phase 3
Status
Completed
Enrollment
1075
Lead sponsor
Vertex Pharmaceuticals Incorporated
Conditions
Acute Pain
Interventions
DRUG: SUZ; DRUG: HB/APAP; DRUG: Placebo (matched to SUZ); DRUG: Placebo (matched to HB/APAP)
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-10-03
Primary completion
2023-12-15
Completion
2023-12-15
Results first posted
2025-08-01
Primary outcomes
  • Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo (0 to 48 hours After First Dose of Study Drug)

NCT05553366 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials