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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04525885




Registration number
NCT04525885
Ethics application status
Date submitted
18/08/2020
Date registered
25/08/2020
Date last updated
12/01/2024

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

Health condition
Health condition(s) or problem(s) studied:
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 twice daily (BID)
Treatment: Drugs - Gefapixant 15 mg BID
Treatment: Drugs - Placebo
Treatment: Drugs - Gefapixant 45 mg BID

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 twice daily (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

Treatment: Drugs: Gefapixant 45 mg BID
Gefapixant 45 mg tablet to be administered orally BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
Timepoint [2] 0 0
Up to 54 weeks
Primary outcome [3] 0 0
Percentage of Participants Who Discontinued Treatment Due to an AE
Timepoint [3] 0 0
Up 52 weeks
Secondary outcome [1] 0 0
Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
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
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
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
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
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
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/09/2022
Sample size
Target
Accrual to date
Final
161
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Fujian
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Inner Mongolia
Country [4] 0 0
China
State/province [4] 0 0
Jiangxi
Country [5] 0 0
China
State/province [5] 0 0
Liaoning
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
China
State/province [7] 0 0
Zhejiang
Country [8] 0 0
China
State/province [8] 0 0
Beijing

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
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/study/NCT04525885
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04525885