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

  • STATUS
    Recruiting
  • End date
    Jul 22, 2021
  • participants needed
    414
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 November 2020
Investigator
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
gefapixant

Summary

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.

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

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet