Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
- Registration Number
- NCT03569033
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo BID Placebo Participants will receive a matching placebo tablet BID for 7 days. Gefapixant 45 mg BID Gefapixant Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days.
- Primary Outcome Measures
Name Time Method Awake Coughs Per Hour on Day 3 Day 3 Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3 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 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.
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) 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.
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3 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) 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.
Trial Locations
- Locations (1)
Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)
🇬🇧London, United Kingdom