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Trial record 64 of 146 for:    Hydrocodone

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

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ClinicalTrials.gov Identifier: NCT03206749
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
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
Actual Study Start Date : June 29, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 8, 2017

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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

  7. 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.

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

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

  10. 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.

  11. 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.

  12. 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.



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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

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.


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


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

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT03206749     History of Changes
Other Study ID Numbers: VX16-150-103
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
Hydrocodone
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
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