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

NCT03206749 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: VX16-150-103
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

  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

  0 to 48 hours after the first dose

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

  up to 6 hours after the first dose

• Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo

  up to 6 hours after the first dose

• Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo

  up to 48 hours after the first dose

Study Arms (3)

VX-150

EXPERIMENTAL

Drug: VX-150

Hydrocodone Bitartrate/Acetaminophen (HB/APAP)

ACTIVE COMPARATOR

Drug: HB/APAP

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

VX-150

HB/APAP DRUG

Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.

Hydrocodone Bitartrate/Acetaminophen (HB/APAP)

Placebo DRUG

Participants received placebo matched to VX-150 and HB/APAP for 2 days.

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:

• Prior to Surgery:
• Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive
• 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 ≥4 on the 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:

• Prior to 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
• Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen
• For female subjects: Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
• For male subjects: Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
• After Surgery:
• Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (4)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: June 29, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 8, 2017
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-01

Locations

US (4)