A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

NCT03764072 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VX18-150-104
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

Brief Summary

This study will evaluate the dose-response relationship and safety of VX-150 in treating acute pain following bunionectomy.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After 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 First Dose

Secondary Outcomes (9)

• Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose

  0 to 48 Hours After First Dose

• Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo

  From Baseline at 24 Hours After First Dose

• Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo

  From Baseline at 24 Hours After First Dose

• Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo

  From Baseline at 24 Hours After First Dose

• Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo

  Up to 6 hours After the First Dose

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Participants received placebo matched to VX-150 for 2 days.

Drug: Placebo

VX-150 - Dose Level 1

EXPERIMENTAL

Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.

Drug: VX-150

VX-150 - Dose Level 2

EXPERIMENTAL

Participants received VX-150 1000 mg once daily (qd) for 2 days.

Drug: VX-150

VX-150 - Dose Level 3

EXPERIMENTAL

Participants received VX-150 500 mg q12h for 2 days.

Drug: VX-150

VX-150 - Dose Level 4

EXPERIMENTAL

Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.

Drug: VX-150

VX-150 - Dose Level 5

EXPERIMENTAL

Participants received VX-150 250 mg qd for 2 days.

Drug: VX-150

Interventions

VX-150 DRUG

Capsules for oral administration.

VX-150 - Dose Level 1; VX-150 - Dose Level 2; VX-150 - Dose Level 3; VX-150 - Dose Level 4; VX-150 - Dose Level 5

Placebo DRUG

Capsules for oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Before surgery:
• Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m\^2)
• Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure
• After surgery:
• Subject reported pain of greater than or equal to (\>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
• Subject is lucid and able to follow commands
• All analgesic guidelines were followed during and after the bunionectomy

You may not qualify if:

• Before surgery:
• History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
• History of abnormal laboratory results \>=2.5\*upper limit of normal (ULN)
• History of peripheral neuropathy
• A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
• Prior medical history of bunionectomy or other foot surgery on the index foot
• History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen
• After surgery:
• Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (6)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Monitor
• Organization: Vertex Pharmaceuticals Incorporated

medicalinfo@vrtx.com

617-341-6777

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: December 12, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 25, 2019
• Last Updated: February 9, 2022
• Results First Posted: February 9, 2022

Record last verified: 2022-01

Locations

US (6)