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This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-150 | Experimental |
| |
| Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-150 | Drug | Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of the Pain Intensity Difference (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose | 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). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score). | 0 to 24 hours after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 2 to 24 Hours After the First Dose | 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). SPID22 was calculated from 2 to 24 hours and the score range was -220 (worst score) to 220 (best score). |
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Inclusion Criteria:
Prior to Surgery:
After Surgery:
Exclusion Criteria:
Prior to 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 | 85023 | United States | ||
| Anaheim Clinical Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | VX-150 | Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days. |
| FG001 | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days. |
| FG002 | Placebo | Participants received placebo matched to VX-150 and HB/APAP for 2 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VX-150 | Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days. |
| BG001 | HB/APAP | Participants received HB 5 mg/APAP 325 mg q6h for 2 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose | 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). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score). | Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 24 hours after the first dose |
|
From Day 1 up to Day 10
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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 | VX-150 | Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | 617-341-6777 | medicalinfo@vrtx.com |
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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 | Aug 30, 2017 | Nov 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2017 | Nov 24, 2020 | SAP_001.pdf |
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| 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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| HB/APAP | Drug | Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days. |
|
| Placebo | Drug | Participants received placebo matched to VX-150 and HB/APAP for 2 days. |
|
| 2 to 24 hours after the first dose |
| Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 0 to 48 Hours After the First Dose | 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). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score). | 0 to 48 hours after the first dose |
| Time to Onset of Perceptible Pain Relief After the First Dose of VX-150 Versus Placebo | Time to onset of perceptible pain relief (any pain relief at all after the first dose) reported based on the first stopwatch assessment. | up to 6 hours after the first dose |
| Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo | Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the second stopwatch assessment. | up to 6 hours after the first dose |
| Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo | Time to first rescue medication was the time elapsed from the first dose of VX-150 or placebo until the participants received the first dose of rescue medication. | up to 48 hours after the first dose |
| Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo | 0 to 24 hours after the first dose and 24 to 48 hours after the first dose |
| Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo | Total use of rescue medication was calculated as the sum of number of capsules multiplied by capsule strength at each dosing occasion of rescue medication. Rescue medication was ibuprofen (400 mg [oral] every 4 hours (q4h) as needed). | 0 to 24 hours after the first dose and 24 to 48 hours after the first dose |
| Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5) | Day 1 and Day 2 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114 | Day 1 and Day 2 |
| Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114 | Day 1 and Day 2 |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 10 |
| Anaheim |
| California |
| 92801 |
| United States |
| Lotus Clinical Research | Pasadena | California | 91105 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| BG002 | Placebo | Participants received placebo matched to VX-150 and HB/APAP for 2 days. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| Pain Intensity at Baseline (at 0 hours) as Recorded on Numeric Pain Rating Scale (NPRS) | Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. | Mean | Standard Deviation | units on scale |
|
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days. |
| OG001 | Placebo | Participants received placebo matched to VX-150 and HB/APAP for 2 days. |
|
|
|
| Secondary | Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 2 to 24 Hours After the First Dose | 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). SPID22 was calculated from 2 to 24 hours and the score range was -220 (worst score) to 220 (best score). | FAS. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Least Squares Mean | Standard Error | units on a scale | 2 to 24 hours after the first dose |
|
|
|
|
| Secondary | Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 0 to 48 Hours After the First Dose | 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). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score). | FAS. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 48 hours after the first dose |
|
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|
|
| Secondary | Time to Onset of Perceptible Pain Relief After the First Dose of VX-150 Versus Placebo | Time to onset of perceptible pain relief (any pain relief at all after the first dose) reported based on the first stopwatch assessment. | FAS. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Median | Full Range | minutes | up to 6 hours after the first dose |
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|
|
| Secondary | Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo | Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the second stopwatch assessment. | FAS. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Median | Full Range | minutes | up to 6 hours after the first dose |
|
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|
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| Secondary | Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo | Time to first rescue medication was the time elapsed from the first dose of VX-150 or placebo until the participants received the first dose of rescue medication. | FAS. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Median | Full Range | hours | up to 48 hours after the first dose |
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| Secondary | Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo | FAS. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Number | percentage of participants | 0 to 24 hours after the first dose and 24 to 48 hours after the first dose |
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| Secondary | Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo | Total use of rescue medication was calculated as the sum of number of capsules multiplied by capsule strength at each dosing occasion of rescue medication. Rescue medication was ibuprofen (400 mg [oral] every 4 hours (q4h) as needed). | FAS. As a standard-of-care reference arm, the "HB/APAP" arm was not intended for statistical comparisons to VX-150. | Posted | Mean | Standard Deviation | mg | 0 to 24 hours after the first dose and 24 to 48 hours after the first dose |
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| Secondary | Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5) | The pharmacokinetic (PK) set included all randomized participants who received at least 1 dose of study drug. Here "Number Analyzed" signifies those participants who were evaluable at specified time points. This outcome measure is applicable to VX-150 arm only. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Day 1 and Day 2 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114 | PK set. Here "Number Analyzed" signifies those participants who were evaluable at specified time points. This outcome measure is applicable to VX-150 arm only. | Posted | Median | Full Range | hours | Day 1 and Day 2 |
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| Secondary | Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114 | PK set. Here "Number Analyzed" signifies those participants who were evaluable at specified time points. This outcome measure is applicable to VX-150 arm only. | Posted | Mean | Standard Deviation | microgram*hour per milliliter (mcg*h/mL) | Day 1 and Day 2 |
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| Secondary | Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | The Safety Set was included all participants who received at least 1 dose of study drug. | Posted | Number | participants | From Day 1 up to Day 10 |
|
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|
| 0 |
| 80 |
| 0 |
| 80 |
| 20 |
| 80 |
| EG001 | HB/APAP | Participants received HB 5 mg/APAP 325 mg q6h for 2 days. | 0 | 81 | 0 | 81 | 22 | 81 |
| EG002 | Placebo | Participants received placebo matched to VX-150 and HB/APAP for 2 days. | 0 | 82 | 0 | 82 | 23 | 82 |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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Greater than (>) 24 - 48 hours |
| Superiority |
>24 - 48 hours |
| Superiority |
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| VRT- 1268114 Day 1 |
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| VRT- 1268114 Day 2 |
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| Title | Measurements |
|---|---|
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| VRT- 1268114 Day 1 |
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| VRT- 1268114 Day 2 |
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| VRT- 1268114 Day 1 |
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| VRT- 1268114 Day 2 |
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