Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

  • End date
    Jul 22, 2021
  • participants needed
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 November 2020
Toll Free Number
Primary Contact
Zhytomyr Central City Hospital #1 ( Site 2807) (0.0 mi away) Contact
+80 other location
chest radiograph
unexplained chronic cough
refractory chronic cough


The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.

Treatment Placebo, Gefapixant
Clinical Study IdentifierNCT04193202
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 November 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Cough or Chronic Cough?
Do you have any of these conditions: Cough or coughing or Chronic Cough?
Do you have any of these conditions: coughing or Cough or Chronic Cough?
Do you have any of these conditions: Chronic Cough or Cough or coughing?
Chest radiograph or computerized topography (CT) scan of the thorax performed after the onset of cough symptoms but before the diagnosis of chronic cough require consultation with the Sponsor to determine if acceptable for inclusion in study
Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (<14 months after onset of cough symptoms)
Has a diagnosis of refractory chronic cough or unexplained chronic cough
Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance

Exclusion Criteria

Is a current smoker
Has given up smoking within 12 months of screening
Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
Has a history of chronic bronchitis, defined as cough that produces >1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
Has a history of malignancy 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
Has a known allergy to gefapixant or its excipients
Has donated or lost 1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
Has previously received gefapixant
Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
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