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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193202
Recruitment Status : Active, not recruiting
First Posted : December 10, 2019
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Cough Drug: Gefapixant Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : November 9, 2021
Estimated Study Completion Date : November 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Gefapixant
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Drug: Gefapixant
Administered twice daily as an oral tablet of 45 mg
Other Name: MK-7264

Placebo Comparator: Placebo
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Drug: Placebo
Administered twice daily as a placebo oral tablet matching gefapixant




Primary Outcome Measures :
  1. Change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12 [ Time Frame: Baseline, Week 12 ]
    Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score will be calculated.


Secondary Outcome Measures :
  1. Change from baseline in the Cough Severity Visual Analog Scale (VAS) score at Week 12 [ Time Frame: Baseline, Week 12 ]
    Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score will be calculated.

  2. Percentage of participants with one or more adverse events (AEs) [ Time Frame: Up to ~Week 14 ]
    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs will be calculated.

  3. Percentage of participants who discontinue study drug due to an AE [ Time Frame: Up to Week 12 ]
    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be calculated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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): NCT04193202


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04193202    
Other Study ID Numbers: 7264-043
2019-002308-42 ( EudraCT Number )
MK-7264-043 ( Other Identifier: Merck Protocol Number )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Cough
Respiration disorders
Respiratory tract diseases
Signs and symptoms, respiratory
Signs and symptoms
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory