Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

Overview

The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).

Full Title of Study: “A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 31, 2018

Interventions

  • Drug: Gefapixant
    • Gefapixant 45 mg will be administered orally.
  • Drug: Placebo
    • Placebo tablet matching gefapixant will be administered orally.

Arms, Groups and Cohorts

  • Experimental: Gefapixant 45 mg BID
    • Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days.
  • Placebo Comparator: Placebo BID
    • Participants will receive a matching placebo tablet BID for 7 days.

Clinical Trial Outcome Measures

Primary Measures

  • Awake Coughs Per Hour on Day 3
    • Time Frame: Day 3
    • Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.

Secondary Measures

  • Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3
    • Time Frame: Baseline and Day 3
    • The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.
  • Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3
    • Time Frame: Baseline and Day 3
    • The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of “today” (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3.
  • Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3
    • Time Frame: Baseline and Day 3
    • The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants’ perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3.
  • Percentage of Participants Who Experienced One or More Adverse Events (AEs)
    • Time Frame: Up to 21 days
    • An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
  • Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
    • Time Frame: Up to Day 7
    • An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Participating in This Clinical Trial

Inclusion Criteria

  • In good general health – Susceptible to human rhinovirus type 16 (HRV-16) – Male or non-pregnant and non-breast feeding female – If female of reproductive potential, agrees to use 1 form of acceptable birth control Exclusion Criteria:

  • Donated blood within 56 days or donated plasma within 7 days prior to dosing – History of significant multiple and/or severe allergies – Recent history of respiratory tract infection – History of cancer – Body mass index <18 kg/m^2 or ≥40 kg/m^2 – History of major surgery or loss of 1 unit of blood – History of allergic reaction to sulfonamides – Received medications within 14 days prior to randomization – Significantly abnormal laboratory tests at Screening – Current smoker, smoked within 5 years of Screening, or significant past smoking history – History of alcohol or drug abuse

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme LLC

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