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

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ClinicalTrials.gov Identifier: NCT03764072
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

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

Condition or disease Intervention/treatment Phase
Acute Pain Drug: VX-150 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2B Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : January 25, 2019

Arm Intervention/treatment
Experimental: VX-150 Drug: VX-150
Multiple doses for VX-150 will be administrated orally.

Placebo Comparator: Placebo Drug: Placebo
Subjects will receive placebo matched to VX-150 orally.




Primary Outcome Measures :
  1. Time-weighted Sum of Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose [ Time Frame: 0 to 24 hours after first dose ]

Secondary Outcome Measures :
  1. Time-weighted Sum of Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After First Dose [ Time Frame: 0 to 48 hours after first dose ]
  2. Proportion of Subjects With at Least 30 Percent (%), 50%, or 70% Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo [ Time Frame: 24 hours after first dose ]
  3. Time to Onset of "Confirmed Perceptible Pain Relief" and "Meaningful Pain Relief" After First Dose of VX-150 Versus Placebo [ Time Frame: Day 1 ]
  4. Plasma Pharmacokinetic Parameters of VRT-1207355 (Active Moiety) and Metabolite M5: Cmax [ Time Frame: pre-dose up to 12 hours after the last dose on Day 3 ]
  5. Plasma Pharmacokinetic Parameters of VRT-1207355 (Active Moiety) and Metabolite M5: AUC [ Time Frame: pre-dose up to 12 hours after the last dose on Day 3 ]
  6. Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From signing of informed consent form to safety follow-up, up to 9 days after last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Other protocol defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

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): NCT03764072


Locations
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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
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Texas
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
United States, Utah
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated

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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT03764072     History of Changes
Other Study ID Numbers: VX18-150-104
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms