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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03449147




Registration number
NCT03449147
Ethics application status
Date submitted
22/02/2018
Date registered
22/02/2018
Date last updated
24/01/2019

Titles & IDs
Public title
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
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)
Secondary ID [1] 0 0
MK-7264-030-02
Secondary ID [2] 0 0
7264-030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Cough 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gefapixant 45 mg BID
Treatment: Drugs - Gefapixant 15 mg BID
Treatment: Drugs - Placebo

Experimental: Gefapixant 45 mg BID - Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).

Experimental: Gefapixant 15 mg BID - Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).

Placebo Comparator: Placebo - Participants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period.


Treatment: Drugs: Gefapixant 45 mg BID
Gefapixant 45 mg tablet to be administered orally BID

Treatment: Drugs: Gefapixant 15 mg BID
Gefapixant 15 mg tablet to be administered orally BID

Treatment: Drugs: Placebo
Placebo tablet administered orally BID

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24-hour Coughs per Hour at Week 24 - Assessment of 24-hour coughs per hour (average hourly cough frequency based on 24-hour sound recordings), to be evaluated using a digital recording device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone.
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up - Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
Timepoint [2] 0 0
Up to 54 weeks
Primary outcome [3] 0 0
Percentage of Participants Who Have a Study Drug Discontinued Due to an AE - Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).
Timepoint [3] 0 0
Up 52 weeks
Secondary outcome [1] 0 0
Change From Baseline of Awake Coughs Per Hour at Week 24 - To evaluate the efficacy of gefapixant by assessment of coughs per hour while the participant is awake, evaluated using a chest contact sensor to record sounds from the lungs and trachea and a lapel microphone to record ambient sounds.
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of Participants With a =1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 - To evaluate the ability of gefapixant to provide a clinically significant improvement in cough-specific health related quality of life (HRQoL), as indicated by a =1.3-point increase from Baseline in the LCQ total score at Week 24. The 19-item LCQ assesses the impact of cough severity in three 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.
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Percentage of Participants With a =30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24 - To evaluate the efficacy of gefapixant based on clinically meaningful (=30%) reduction from Baseline in 24-hour coughs per hour at Week 24. Coughs per hour are evaluated using a chest contact sensor to record sounds from the lungs and trachea and a lapel microphone to record ambient sounds.
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Percentage of Participants with =1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 - To evaluate the efficacy of gefapixant based on the percentage of participants with =1.3-point reduction of the mean weekly CSD total score at Week 24. Participants will record their cough frequency, intensity, and disruption due to cough using the 7-item CSD. Participants will rate each item using an 11-point scale ranging from 0 to 10 with higher scores indicating greater severity.
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Percentage of Participants with =2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24 - To evaluate the efficacy of gefapixant based on the percentage of participants with =2.7-point reduction of the mean weekly CSD total score at Week 24. Participants will record their cough frequency, intensity, and disruption due to cough using the 7-item CSD. Participants will rate each item using an 11-point scale ranging from 0 to 10 with higher scores indicating greater severity.
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Percentage of Participants With a =30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 - To evaluate the efficacy of gefapixant based on improvement from Baseline in cough severity, assessed by the proportion of participants with a =30 mm reduction from baseline in Cough Severity VAS score at Week 24. 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").
Timepoint [6] 0 0
Baseline, Week 24

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 or is currently participating in or has
participated in an interventional clinical study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Australian Clinical Research Network ( Site 0201) - Maroubra
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice ( Site 0206) - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital [Adelaide, Australia] ( Site 0214) - Adelaide
Recruitment hospital [4] 0 0
Trialswest ( Site 0208) - Murdoch
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264)
in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at
least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24
hours) at Week 24.
Trial website
https://clinicaltrials.gov/show/NCT03449147
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable