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The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-993 | Experimental | Participants will be randomized to receive different dose levels of VX-993. |
|
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | Active Comparator | Participants will be randomized to receive HB/APAP. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive placebo matched to VX-993 and HB/APAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-993 | Drug | Tablets for oral administration. |
| |
| HB/APAP |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) | From 0 to 48 Hours After the First Dose of Study Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours | At 48 Hours After the First Dose of Study Drug | |
| Proportion of Participants With >=50% Reduction in NPRS at 48 Hours | At 48 Hours After the First Dose of Study Drug |
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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 |
|---|---|---|---|---|---|---|
| Shoals Medical Trials Inc. | Sheffield | Alabama | 35660 | United States | ||
| Arizona Research Center |
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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| Drug |
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. |
|
| Proportion of Participants With >=70% Reduction in NPRS at 48 Hours | At 48 Hours After the First Dose of Study Drug |
| Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite | 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 | 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 | 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) | Day 1 up to Day 19 |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States |
| Trovare Clinical Research | Bakersfield | California | 93301 | United States |
| New Hope Research Development | Tarzana, CA | Tarzana | California | 91356 | United States |
| Clinical Pharmacology of Miami | Miami | Florida | 33172 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | United States |
| HD Research LLC | First Surgical Hospital | Bellaire | Texas | 77401 | United States |
| HD Research LLC | Legent Orthopedic Hospital | Carrollton | Texas | 75006 | United States |
| Memorial Hermann Village | Houston | Texas | 77043 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| 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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