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

Phase 2

Completed

• Conditions: Acute Pain
• Interventions: Drug: Placebo (matched to VX-548); Drug: HB/APAP; Drug: VX-548; Drug: Placebo (matched to HB/APAP)

• Registration Number: NCT05034952
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study Start: 2021-08-30
• Study First Posted: 2021-09-05
• Primary Completion: 2021-12-05
• Study Completion: 2021-12-21
• Disposition First Submitted: 2022-12-02
• Disposition First Submitted QC: 2022-12-02
• Disposition First Posted: 2022-12-07
• Status Verified: 2024-12
• Results First Submitted: 2024-12-02
• Results First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

• 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)

Key Exclusion Criteria

• 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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (matched to VX-548)	Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days.
Placebo	Placebo (matched to HB/APAP)	Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days.
HB/APAP	HB/APAP	Participants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days.
VX-548: Low Dose	VX-548	Participants 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	VX-548	Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug	0 to 24 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). SPIDr0-24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug	From Baseline At 48 Hours After 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.
Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug	From Baseline At 48 Hours After 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.
Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug	From Baseline at 48 Hours After 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.
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

Trial Locations

Locations (7)

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Chesapeake Research Group; 🇺🇸 Pasadena, Maryland, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

First Surgical Hospital; 🇺🇸 Bellaire, Texas, United States

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States