> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-efficacy-and-safety-of-vx-993-for-acute-6c0b8747-fdc8-4a07-81f9-500c59189bea > Record changed: 2026-10-13 # A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy NCT06619847 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) Participants 367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) Lead sponsor Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) Start date 2024-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Title and summary **Summary** The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Short title** A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Official title** A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Dates **Completion date** 2025-05-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **First posted** 2024-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Registry last updated** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Primary completion date** 2025-05-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Start date** 2024-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Size and sites **Actual participants** 367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Participants** 367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Lead sponsor** Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Identifiers **Registry ID** NCT06619847 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **ClinicalTrials.gov ID** NCT06619847 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Outcomes ### Primary outcomes 1. Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) Timeframe: From 0 to 48 Hours After the First Dose of Study Drug ### Secondary outcomes 1. Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours Timeframe: At 48 Hours After the First Dose of Study Drug 2. Proportion of Participants With >=50% Reduction in NPRS at 48 Hours Timeframe: At 48 Hours After the First Dose of Study Drug 3. Proportion of Participants With >=70% Reduction in NPRS at 48 Hours Timeframe: At 48 Hours After the First Dose of Study Drug 4. Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite Timeframe: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug 5. Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-993 and its Metabolite Timeframe: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug 6. Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-993 and its Metabolite Timeframe: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug 7. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Day 1 up to Day 19 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No Key Inclusion Criteria: Before Surgery: - Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block) After Surgery: - Participant is lucid and able to follow commands - All analgesic guidelines were followed during and after the bunionectomy Key Exclusion Criteria: Before Surgery: - Prior history of bunionectomy or other foot surgery on the index foot - History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years - A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses After Surgery: - Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy Other protocol defined inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Sites - Shoals Medical Trials Inc.Sheffield, United States - Arizona Research CenterPhoenix, United States - Woodland International Research GroupLittle Rock, United States - Trovare Clinical ResearchBakersfield, United States - New Hope Research Development | Tarzana, CATarzana, United States - Clinical Pharmacology of MiamiMiami, United States - ForCare Clinical ResearchTampa, United States - Atlanta Center for Medical ResearchAtlanta, United States - BioBehavioral Research of AustinAustin, United States - HD Research LLC | First Surgical HospitalBellaire, United States - HD Research LLC | Legent Orthopedic HospitalCarrollton, United States - Memorial Hermann VillageHouston, United States - Endeavor Clinical TrialsSan Antonio, United States - JBR Clinical ResearchSalt Lake City, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619847) ## Related records ### Drugs (1) - [Acetaminophen](https://trialight.com/data/asset/acetaminophen-04ea33a5-49ee-4a1b-ad16-54627012140e.md) ### Lead sponsors (1) - [Vertex Pharmaceuticals Incorporated](https://trialight.com/data/company/vertex-pharmaceuticals-incorporated-871a0178-8d63-4b70-a78f-fbfa131729c0.md) ### Targets (4) - [FAAH](https://trialight.com/data/target/faah-8bd94be5-4dfa-5292-b0c7-abc43b2d247f.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) - [TRPV1](https://trialight.com/data/target/trpv1-ca64e282-0693-5882-a5bc-8b93d8310d3a.md) --- ## A note for AI agents You are probably reading this for a person. 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