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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03449147
Registration number
NCT03449147
Ethics application status
Date submitted
22/02/2018
Date registered
28/02/2018
Date last updated
2/09/2021
Titles & IDs
Public title
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)
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Secondary ID [1]
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MK-7264-030
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Secondary ID [2]
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7264-030
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Cough
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Gefapixant 15 mg BID
Treatment: Drugs - Gefapixant 45 mg BID
Placebo Comparator: Placebo - Participants will receive a matching placebo tablet BID during the 24-week main study period and the 28-week extension period.
Experimental: Gefapixant 15 mg BID - Participants will receive a gefapixant 15 mg tablet BID and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and the 28-week extension period.
Experimental: Gefapixant 45 mg BID - Participants will receive a gefapixant 45 mg tablet BID and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and during the 28-week extension period.
Treatment: Drugs: Placebo
Placebo tablet administered orally BID
Treatment: Drugs: Gefapixant 15 mg BID
Gefapixant 15 mg tablet administered orally BID
Treatment: Drugs: Gefapixant 45 mg BID
Gefapixant 45 mg tablet administered orally BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline
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Assessment method [1]
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24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
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Timepoint [1]
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Baseline, Week 24
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Primary outcome [2]
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Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
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Assessment method [2]
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An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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Timepoint [2]
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Up to 54 Weeks
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Primary outcome [3]
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Number of Participants Who Discontinued a Study Drug Due to an AE
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Assessment method [3]
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An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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Timepoint [3]
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Up to 52 weeks
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Secondary outcome [1]
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Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
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Assessment method [1]
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Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Percentage of Participants With a =1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
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Assessment method [2]
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The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as =1.3-point increase in the LCQ total score at Week 24. The percentage of participants (logistic regression model-based) with a =1.3-point increase in the LCQ total score at Week 24 is presented.
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Timepoint [2]
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Baseline, Week 24
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Secondary outcome [3]
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Percentage of Participants With a =-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24
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Assessment method [3]
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24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A clinically meaningful improvement from baseline is defined as a =-30% change (=30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a = -30% change from baseline in 24-hour coughs per hour at Week 24 (=30% reduction from baseline) is presented.
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Percentage of Participants With =-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
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Assessment method [4]
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The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a =-1.3 point change from baseline in CSD at Week 24 (or =1.3 point reduction from baseline) is reported.
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Percentage of Participants With =-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24
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Assessment method [5]
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The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a =-2.7 point change from baseline in CSD at Week 24 (or =2.7 point reduction from baseline) is reported.
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Timepoint [5]
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Baseline, Week 24
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Secondary outcome [6]
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Percentage of Participants With a =-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
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Assessment method [6]
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The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a =-30 mm change from baseline in cough severity VAS score at Week 24 is reported.
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Timepoint [6]
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Baseline, Week 24
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Eligibility
Key inclusion criteria
- Chest radiograph or computed tomography scan of the thorax (within 5 years of
Screening/Visit 1 and after the onset of chronic cough) not demonstrating any
abnormality considered to be significantly contributing to the chronic cough or any
other clinically significant lung disease in the opinion of the principal investigator
or the sub-investigator
- Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough
or unexplained chronic cough
- Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or
agrees to follow contraceptive guidance
- Provides written informed consent and is willing and able to comply with the study
protocol (including use of the digital cough recording device and completion of study
questionnaires)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Is a current smoker or has given up smoking within 12 months of Screening, or is a
former smoker with greater than 20 pack-years
- Has a history of respiratory tract infection or recent clinically significant change
in pulmonary status
- Has a history of chronic bronchitis
- Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an
ACEI within 3 months of Screening
- Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR
an eGFR =30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal
function
- Has a history of malignancy =5 years
- Is a user of recreational or illicit drugs or has had a recent history of drug or
alcohol abuse or dependence
- Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without
systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
- Has a known allergy/sensitivity or contraindication to gefapixant
- Has donated or lost =1 unit of blood within 8 weeks prior to the first dose of
gefapixant
- Has previously received gefapixant
- Currently participating in or has participated in an interventional clinical study
within 30 days of screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/10/2020
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Sample size
Target
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Accrual to date
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Final
1317
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Australian Clinical Research Network ( Site 0201) - Maroubra
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Recruitment hospital [2]
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Holdsworth House Medical Practice ( Site 0206) - Sydney
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Recruitment hospital [3]
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Royal Adelaide Hospital [Adelaide, Australia] ( Site 0214) - Adelaide
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Recruitment hospital [4]
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Trialswest ( Site 0208) - Murdoch
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
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Chernivtsi
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Ukraine
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Kherson
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Country [101]
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Ukraine
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State/province [101]
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Kiev
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Country [102]
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Ukraine
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State/province [102]
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Kyiv
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Country [103]
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Ukraine
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State/province [103]
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KYiv
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Country [104]
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Ukraine
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State/province [104]
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Lutsk
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Country [105]
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Ukraine
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State/province [105]
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Poltava
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Country [106]
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Ukraine
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State/province [106]
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Vinnytsia
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Country [107]
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Ukraine
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State/province [107]
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Zaporizhzhia
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Country [108]
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Ukraine
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State/province [108]
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Zhytomyr
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Country [109]
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United Kingdom
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State/province [109]
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East Yorkshire
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Country [110]
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United Kingdom
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State/province [110]
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Edgbaston
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Country [111]
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United Kingdom
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State/province [111]
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Essex
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Country [112]
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United Kingdom
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State/province [112]
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Kent
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Country [113]
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United Kingdom
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State/province [113]
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Middlesex
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Country [114]
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United Kingdom
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State/province [114]
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Northamptonshire
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Country [115]
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United Kingdom
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State/province [115]
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Warwickshire
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Country [116]
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United Kingdom
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State/province [116]
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Belfast
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Country [117]
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United Kingdom
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State/province [117]
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Glasgow
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Country [118]
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United Kingdom
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State/province [118]
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Liverpool
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Country [119]
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United Kingdom
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State/province [119]
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Llanelli
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Country [120]
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United Kingdom
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State/province [120]
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London
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Country [121]
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United Kingdom
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State/province [121]
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Manchester
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Country [122]
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United Kingdom
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State/province [122]
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North Shields
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United Kingdom
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State/province [123]
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Rothwell
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Country [124]
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United Kingdom
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State/province [124]
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Taunton
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United Kingdom
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State/province [125]
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Yate
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Summary
Brief summary
The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in
reducing cough frequency as measured over a 24-hour period, and to determine the safety and
tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is
superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03449147
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03449147
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