Acute PainPhase 2NCT06619847
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
A Phase 2 study testing VX-993 and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- VX-993 and HB/APAP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 14 sitesUnited States
- Study dates
- 29 Oct 2024to 27 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
BioBehavioral Research of Austin
Austin, Texas, 78759
Trovare Clinical Research
Bakersfield, California, 93301
HD Research LLC | First Surgical Hospital
Bellaire, Texas, 77401
HD Research LLC | Legent Orthopedic Hospital
Carrollton, Texas, 75006
Memorial Hermann Village
Houston, Texas, 77043
Woodland International Research Group
Little Rock, Arkansas, 72211
Clinical Pharmacology of Miami
Miami, Florida, 33172
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research
Salt Lake City, Utah, 84107
Endeavor Clinical Trials
San Antonio, Texas, 78240
Shoals Medical Trials Inc.
Sheffield, Alabama, 35660
ForCare Clinical Research
Tampa, Florida, 33613
New Hope Research Development | Tarzana, CA
Tarzana, California, 91356
About this study
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
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.
- Conditions
- Acute Pain
- Being tested
- VX-993, HB/APAP, Placebo (matched to VX-993), Placebo (matched to HB/APAP)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-993Drug
Tablets for oral administration.
HB/APAPDrug
Capsules for oral administration.
Placebo (matched to VX-993)Drug
Placebo matched to VX-993 for oral administration.
Placebo (matched to HB/APAP)Drug
Placebo matched to HB/APAP for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| VX-993 | Experimental | Participants will be randomized to receive different dose levels of VX-993. Receives: Drug: VX-993; Drug: Placebo (matched to HB/APAP) |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | Active comparator | Participants will be randomized to receive HB/APAP. Receives: Drug: HB/APAP; Drug: Placebo (matched to VX-993) |
| Placebo | Placebo comparator | Participants will be randomized to receive placebo matched to VX-993 and HB/APAP Receives: Drug: Placebo (matched to VX-993); Drug: Placebo (matched to HB/APAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)
Measured: From 0 to 48 Hours After the First Dose of Study Drug
Secondary outcomes (7)
Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours
Measured: At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=50% Reduction in NPRS at 48 Hours
Measured: At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=70% Reduction in NPRS at 48 Hours
Measured: At 48 Hours After the First Dose of Study Drug
Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite
Measured: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-993 and its Metabolite
Measured: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-993 and its Metabolite
Measured: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start29 Oct 2024
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619847
- Sponsor's protocol ID
- VX24-993-101
- Status last verified
- May 2026
- First submitted
- 27 Sep 2024
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06619847
- Acronym / sponsor ID
- VX24-993-101
- Conditions
- Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VX-993 | Experimental | Drug: VX-993, Drug: Placebo (matched to HB/APAP)Participants will be randomized to receive different dose levels of VX-993. |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | Active comparator | Drug: HB/APAP, Drug: Placebo (matched to VX-993)Participants will be randomized to receive HB/APAP. |
| Placebo | Placebo comparator | Drug: Placebo (matched to VX-993), Drug: Placebo (matched to HB/APAP)Participants will be randomized to receive placebo matched to VX-993 and HB/APAP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- Participant is lucid and able to follow commands
- All analgesic guidelines were followed during and after the bunionectomy
Key exclusion criteria (7 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-993Tablets for oral administration. | Drug | VX-993 |
| HB/APAPCapsules for oral administration. | Drug | Hydrocodone bitartrate/acetaminophen (HB/APAP) |
| Placebo (matched to VX-993)Placebo matched to VX-993 for oral administration. | Drug | Hydrocodone bitartrate/acetaminophen (HB/APAP), Placebo |
| Placebo (matched to HB/APAP)Placebo matched to HB/APAP for oral administration. | Drug | Placebo, VX-993 |
Primary outcome
Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)
Time frame: From 0 to 48 Hours After the First Dose of Study Drug
7 secondary outcomes
Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours
Time frame: At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=50% Reduction in NPRS at 48 Hours
Time frame: At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=70% Reduction in NPRS at 48 Hours
Time frame: At 48 Hours After the First Dose of Study Drug
Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite
Time frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-993 and its Metabolite
Time frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-993 and its Metabolite
Time frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-993 and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) (time frame: From 0 to 48 Hours After the First Dose of Study Drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.