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Trial record 2 of 3 for:    vx150

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

This study is currently recruiting participants.
Verified August 2017 by Vertex Pharmaceuticals Incorporated
Sponsor:
ClinicalTrials.gov Identifier:
NCT03206749
First Posted: July 2, 2017
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
  Purpose
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.

Condition Intervention Phase
Acute Pain Drug: VX-150 Drug: hydrocodone bitartrate/acetaminophen (HB/APAP) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Time-weighted sum of the pain intensity difference between VX-150 versus placebo as recorded on a Numeric Pain Rating Scale (NPRS) [ Time Frame: 0 to 24 hours after the first dose ]
    Time-weighted sum of the pain intensity difference as recorded on a 11-point NPRS will be reported.


Secondary Outcome Measures:
  • Time-weighted sum of the pain intensity difference between VX-150 versus placebo as recorded on a NPRS [ Time Frame: 2 to 24 hours after the first dose ]
    Time-weighted sum of the pain intensity difference as recorded on a 11-point NPRS will be reported.

  • Time-weighted sum of the pain intensity difference between VX-150 versus placebo as recorded on a NPRS [ Time Frame: 0 to 48 hours after the first dose ]
    Time-weighted sum of the pain intensity difference as recorded on a 11-point NPRS will be reported.

  • Time to onset of "perceptible pain relief" and "meaningful pain relief" after the first dose of VX-150 versus placebo [ Time Frame: up to 12 hours after the first dose ]
    Time to onset of "perceptible pain relief" and "meaningful pain relief" will be reported using double-stopwatch assessment.

  • 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 will be reported. Rescue medication to be administered.

  • Percentage of subjects using rescue medication [ Time Frame: 0 to 24 hours after the first dose ]
    Percentage of subjects using rescue medication will be reported.

  • Total rescue medication use [ Time Frame: 0 to 24 hours after the first dose ]
    Total rescue medication use will be reported.

  • Percentage of subjects using rescue medication [ Time Frame: 24 to 48 hours after the first dose ]
    Percentage of subjects using rescue medication will be reported.

  • Total rescue medication use [ Time Frame: 24 to 48 hours after the first dose ]
    Total rescue medication use will be reported.

  • Plasma PK parameters of VX-150 and its primary metabolite: (Cmax) [ Time Frame: Day 1 and 2 ]
    The maximum plasma concentration will be reported.

  • Plasma PK parameters of VX-150 and its primary metabolite: (Tmax) [ Time Frame: Day 1 and 2 ]
    The time to maximum plasma concentration will be reported.

  • Plasma PK parameters of VX-150 and its primary metabolite: (AUC0-tau) [ Time Frame: Day 1 and 2 ]
    The area under the curve (AUC) from time of dosing up to time t (AUC0-t) will be reported.

  • Safety and tolerability assessments including number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Day 1 up to safety follow-up (up to 7 days after last dose of study drug) ]
    Measured as number of subjects with AEs and SAEs.


Estimated Enrollment: 240
Actual Study Start Date: June 29, 2017
Estimated Study Completion Date: October 12, 2017
Estimated Primary Completion Date: October 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VX-150 Drug: VX-150
Administered orally every 12 hours (q12h) for 2 days.
Experimental: Hydrocodone bitartrate/Acetominophen (HB/APAP) Drug: hydrocodone bitartrate/acetaminophen (HB/APAP)
Administered orally every 6 hours (q6h) for 2 days
Placebo Comparator: Placebo Drug: Placebo

Placebo matched to VX-150 orally q12h for 2 days.

Placebo matched to HB/APAP orally q6h for 2 days.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

  Contacts and Locations
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): NCT03206749


Contacts
Contact: Medical Information 617-341-6777 medicalinfo@vrtx.com

Locations
United States, Arizona
Arizona Research Center Recruiting
Phoenix, Arizona, United States, 85023
United States, California
Anaheim Clinical Trials Recruiting
Anaheim, California, United States, 92801
Lotus Clinical Research Recruiting
Pasadena, California, United States, 91105
United States, Utah
Jean Brown Research Recruiting
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT03206749     History of Changes
Other Study ID Numbers: VX16-150-103
First Submitted: June 29, 2017
First Posted: July 2, 2017
Last Update Posted: August 18, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents