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The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days. |
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| HB/APAP | Active Comparator | Participants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days. |
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| 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. |
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| VX-548: High Dose | Experimental | Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-548 | Drug | Tablets for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 0 to 48 Hours After First Dose of Study Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Key Inclusion Criteria:
Before Surgery:
After Surgery:
Key Exclusion Criteria
Before Surgery:
After Surgery:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Lotus Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37530822 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebos matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days. |
| FG001 | HB/APAP | Participants received HB 5 milligrams (mg) / APAP 325 mg every 6 hours for 2 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2022 | Nov 27, 2024 |
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| HB/APAP | Drug | Capsules for oral administration. |
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| Placebo (matched to VX-548) | Drug | Placebo matched to VX-548 for oral administration. |
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| Placebo (matched to HB/APAP) | Drug | Placebo matched to HB/APAP for oral administration. |
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| 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. | 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. | 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. | 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) | Day 1 up to Day 16 |
| Pasadena |
| California |
| 91105 |
| United States |
| Chesapeake Research Group | Pasadena | Maryland | 21122 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| First Surgical Hospital | Bellaire | Texas | 77401 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| FG002 | VX-548: Low Dose | Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days. |
| FG003 | VX-548: High Dose | Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days. |
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| NOT COMPLETED |
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All randomized participants who had received at least one dose of the study drug during the treatment period were included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to VX-548 and HB/APAP for 2 days. |
| BG001 | HB/APAP | Participants received HB 5 mg / APAP 325 mg q6h for 2 days. |
| BG002 | VX-548: Low Dose | Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days. |
| BG003 | VX-548: High Dose | Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Pain Intensity at Baseline (at 0 hours) as Recorded on Numeric Pain Rating Scale (NPRS) | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 48 Hours After First Dose of Study Drug |
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| Secondary | 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). | FAS. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 24 Hours After First Dose of Study Drug |
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| Secondary | 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. | FAS. | Posted | Number | percentage of participants | From Baseline At 48 Hours After First Dose of Study Drug |
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| Secondary | 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. | FAS. | Posted | Number | percentage of participants | From Baseline At 48 Hours After First Dose of Study Drug |
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| Secondary | 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. | FAS. | Posted | Number | percentage of participants | From Baseline at 48 Hours After First Dose of Study Drug |
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| Secondary | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Day 1 up to Day 16 |
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Day 1 up to Day 16
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to VX-548 and HB/APAP for 2 days. | 0 | 77 | 1 | 77 | 40 | 77 |
| EG001 | HB/APAP | Participants received HB 5 mg / APAP 325 mg q6h for 2 days. | 0 | 76 | 1 | 76 | 37 | 76 |
| EG002 | VX-548 Low Dose | Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days. | 0 | 74 | 1 | 74 | 37 | 74 |
| EG003 | VX-548 High Dose | Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days. | 0 | 76 | 0 | 76 | 33 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | 617-341-6777 | medicalinfo@vrtx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2021 | Nov 27, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| American Indian or Alaska Native |
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| Native Hawaiian or other Pacific Islander |
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| Other |
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| Multiracial |
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| Superiority |
| ANCOVA | 0.0097 | Superiority |
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days. |
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