A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
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ClinicalTrials.gov Identifier: NCT04977336 |
Recruitment Status :
Completed
First Posted : July 26, 2021
Last Update Posted : February 27, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Pain | Drug: VX-548 Drug: HB/APAP Drug: Placebo (matched to VX-548) Drug: Placebo (matched to HB/APAP) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 274 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy |
Actual Study Start Date : | July 19, 2021 |
Actual Primary Completion Date : | February 17, 2022 |
Actual Study Completion Date : | March 4, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: VX-548
Participants will be randomized to receive different dose levels of VX-548.
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Drug: VX-548
Tablets for oral administration. Drug: Placebo (matched to HB/APAP) Placebo matched to HB/APAP for oral administration. |
Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants will receive HB/APAP.
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Drug: HB/APAP
Capsules for oral administration. Drug: Placebo (matched to VX-548) Placebo matched to VX-548 for oral administration. |
Placebo Comparator: Placebo
Participants will receive placebos matched to VX-548 and HB/APAP.
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Drug: Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration. Drug: Placebo (matched to HB/APAP) Placebo matched to HB/APAP for oral administration. |
- Time-weighted sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug [ Time Frame: 0 to 48 Hours After the First Dose of Study Drug ]
- Time-weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug [ Time Frame: 0 to 24 Hours After the First Dose of Study Drug ]
- Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug [ Time Frame: At 48 Hours After the First Dose of Study Drug ]
- Maximum Observed Plasma Concentration (Cmax) of VX-548 [ 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-548 [ 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-548 [ 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 18 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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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 and popliteal sciatic block)
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After Surgery:
- Participant is lucid and able to follow commands
- All analgesic guidelines were followed during and after the bunionectomy
Key Exclusion Criteria:
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Before Surgery:
- Prior history of bunionectomy or other foot surgery on the index foot
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- Any prior surgery within 1 month before the first study drug
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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 that, in the opinion of the investigator, should preclude randomization
Other protocol defined inclusion/exclusion criteria may apply
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977336
United States, Alabama | |
Shoals Medical Trials Inc. | |
Sheffield, Alabama, United States, 35660 | |
United States, Arizona | |
Arizona Research Center | |
Phoenix, Arizona, United States, 85053 | |
United States, California | |
Anaheim Clinical Trials | |
Anaheim, California, United States, 92801 | |
Lotus Clinical Research | |
Pasadena, California, United States, 91105 | |
New Hope Research Development | |
Tarzana, California, United States, 91356 | |
United States, Georgia | |
Atlanta Center for Medical Research | |
Atlanta, Georgia, United States, 30331 | |
United States, Maryland | |
Chesapeake Research Group | |
Pasadena, Maryland, United States, 21122 | |
United States, Ohio | |
Midwest Clinical Research Center | |
Dayton, Ohio, United States, 45417 | |
United States, Texas | |
First Surgical Hospital | |
Bellaire, Texas, United States, 77401 | |
Legent Orthopedic Hospital | |
Carrollton, Texas, United States, 75006 | |
Endeavor Clinical Trials | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
JBR Clinical Research | |
Salt Lake City, Utah, United States, 84107 |
Responsible Party: | Vertex Pharmaceuticals Incorporated |
ClinicalTrials.gov Identifier: | NCT04977336 |
Other Study ID Numbers: |
VX21-548-101 |
First Posted: | July 26, 2021 Key Record Dates |
Last Update Posted: | February 27, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acute Pain Pain Neurologic Manifestations Acetaminophen Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |