Acute PainPhase 2NCT05034952

A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

A Phase 2 study testing VX-548 and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty. 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-548 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: 303 participants
Where: 7 sitesUnited States
Study dates: 30 Aug 2021to 21 Dec 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 an abdominoplasty without collateral procedures
After Surgery:
Participant is lucid and able to follow commands
All analgesic guidelines were followed during and after the abdominoplasty
Abdominoplasty procedure duration <=3 hours without collateral procedures (for example., liposuction)

Who cannot join

Before Surgery:
Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
Any prior surgery within 1 month before the first study drug
After Surgery:
Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
Participant had collateral procedures during the abdominoplasty
Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

First Surgical Hospital
Bellaire, Texas, 77401
Midwest Clinical Research Center
Dayton, Ohio, 45417
Lotus Clinical Research
Pasadena, California, 91105
Chesapeake Research Group
Pasadena, Maryland, 21122
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research
Salt Lake City, Utah, 84107
Endeavor Clinical Trials
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the 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.

Conditions: Acute Pain
Being tested: VX-548, HB/APAP, Placebo (matched to VX-548), 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-548Drug
Also called Suzetrigine
Tablets for oral administration.
HB/APAPDrug
Capsules for oral administration.
Placebo (matched to VX-548)Drug
Placebo matched to VX-548 for oral administration.
Placebo (matched to HB/APAP)Drug
Placebo matched to HB/APAP for oral administration.

Study groups in NCT05034952
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days. Receives: Drug: Placebo (matched to VX-548); Drug: Placebo (matched to HB/APAP)
HB/APAP	Active comparator	Participants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days. Receives: Drug: HB/APAP
VX-548: Low Dose	Experimental	Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days. Receives: Drug: VX-548
VX-548: High Dose	Experimental	Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days. Receives: Drug: VX-548

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug
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).
Measured: 0 to 48 Hours After First Dose of Study Drug

Secondary outcomes (5)

Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug
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). SPIDr0-24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Measured: 0 to 24 Hours After First Dose of Study Drug
Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 48 hours after the first dose of VX-548 or placebo were reported.
Measured: From Baseline At 48 Hours After First Dose of Study Drug
Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP, or placebo were reported.
Measured: From Baseline At 48 Hours After First Dose of Study Drug
Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 70% reduction from baseline in NPRS at 48 hours after the first dose of VX-548,HB/APAP or placebo were reported.
Measured: From Baseline at 48 Hours After First Dose of Study Drug
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to Day 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202121 Dec 2021

First posted5 Sep 2021
Study start30 Aug 2021
Primary completion5 Dec 2021
Study completion21 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05034952
Sponsor's protocol ID: VX21-548-102
Status last verified: Dec 2024
First submitted: 27 Aug 2021
Last updated: 27 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
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

Publications

Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.
PubMed 37530822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
ClinicalTrials.gov ID: NCT05034952
Acronym / sponsor ID: VX21-548-102
Conditions: Acute Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 303 participants (actual)
Lead sponsor: Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
Study start: 30 Aug 2021 (actual)
Primary completion: 5 Dec 2021 (actual)
Study completion: 21 Dec 2021 (actual)
First posted: 5 Sep 2021 (actual)
Results: Posted 27 Dec 2024

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 and safety of VX-548 doses in treating acute pain after an abdominoplasty.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo (matched to VX-548), Drug: Placebo (matched to HB/APAP)Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days.
HB/APAP	Active comparator	Drug: HB/APAPParticipants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days.
VX-548: Low Dose	Experimental	Drug: VX-548Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days.
VX-548: High Dose	Experimental	Drug: VX-548Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Before Surgery:
After Surgery:

Key exclusion criteria (8 listed)

Before Surgery:
After Surgery:
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-548Also: SuzetrigineTablets for oral administration.	Drug	VX-548: High Dose, VX-548: Low Dose
HB/APAPCapsules for oral administration.	Drug	HB/APAP
Placebo (matched to VX-548)Placebo matched to VX-548 for oral administration.	Drug	Placebo
Placebo (matched to HB/APAP)Placebo matched to HB/APAP for oral administration.	Drug	Placebo

Primary outcome

Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug
Time frame: 0 to 48 Hours After First Dose of Study Drug
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).

5 secondary outcomes

Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug
Time frame: 0 to 24 Hours After First Dose of Study Drug
Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
Time frame: From Baseline At 48 Hours After First Dose of Study Drug
Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
Time frame: From Baseline At 48 Hours After First Dose of Study Drug
Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
Time frame: From Baseline at 48 Hours After First Dose of Study Drug
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 16

Results and safety

Results posted to the registry on 27 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	77	75
HB/APAP	76	70
VX-548: Low Dose	74	70
VX-548: High Dose	76	72

Primary outcome: Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug

Time frame: 0 to 48 Hours After First Dose of Study Drug. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 77	HB/APAP n = 76	VX-548: Low Dose n = 74	VX-548: High Dose n = 76
Value	72.73 (10.23)	85.20 (10.30)	95.11 (10.44)	110.53 (10.30)

Placebo vs HB/APAP: p = 0.3914, ANCOVA
Placebo vs VX-548: Low Dose: p = 0.1266, ANCOVA
Placebo vs VX-548: High Dose: p = 0.0097, ANCOVA

Population analysed: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 77 (1.3%)	40 of 77 (51.9%)	0 of 77
HB/APAP	1 of 76 (1.3%)	37 of 76 (48.7%)	0 of 76
VX-548 Low Dose	1 of 74 (1.4%)	37 of 74 (50%)	0 of 74
VX-548 High Dose	0 of 76 (0%)	33 of 76 (43.4%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37530822Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.
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.

7 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-548 and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 7 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 6 inclusion and 8 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug (time frame: 0 to 48 Hours After 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?

On the ClinicalTrials.gov record for NCT05034952, which also lists 1 linked publication.

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 27 Dec 2024.