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NCT Number: NCT03206749

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Research Center, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Other protocol defined inclusion/exclusion criteria may apply.

Treatment and study plan

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.

HB/APAP

Drug

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

Placebo

Drug

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

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

    Time frame: 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).

Secondary outcomes

  1. 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

    Time frame: 2 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). SPID22 was calculated from 2 to 24 hours and the score range was -220 (worst score) to 220 (best score).

  2. 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

    Time frame: 0 to 48 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). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

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

    Time frame: up to 6 hours after the first dose

    Time to onset of perceptible pain relief (any pain relief at all after the first dose) reported based on the first stopwatch assessment.

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

    Time frame: up to 6 hours after the first dose

    Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the second stopwatch assessment.

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

    Time frame: up to 48 hours after the first dose

    Time to first rescue medication was the time elapsed from the first dose of VX-150 or placebo until the participants received the first dose of rescue medication.

  6. Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo

    Time frame: 0 to 24 hours after the first dose and 24 to 48 hours after the first dose

  7. Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo

    Time frame: 0 to 24 hours after the first dose and 24 to 48 hours after the first dose

    Total use of rescue medication was calculated as the sum of number of capsules multiplied by capsule strength at each dosing occasion of rescue medication. Rescue medication was ibuprofen (400 mg [oral] every 4 hours (q4h) as needed).

  8. Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)

    Time frame: Day 1 and Day 2

  9. Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114

    Time frame: Day 1 and Day 2

  10. Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114

    Time frame: Day 1 and Day 2

  11. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Day 10

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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