Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03449147
Ethics application status
Date submitted
22/02/2018
Date registered
28/02/2018

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
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 - 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
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/Baseline
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Number 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
Number of Participants Who Discontinued a Study Drug Due to an AE
Timepoint [3] 0 0
Up to 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 Change 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% Change 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 Change 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 Change 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 Millimeter (mm) Change 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
* Currently participating in or has participated in an interventional clinical study within 30 days of screening

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
15/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2020
Sample size
Target
Accrual to date
Final
1317
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
China
State/province [26] 0 0
Fujian
Country [27] 0 0
China
State/province [27] 0 0
Guangdong
Country [28] 0 0
China
State/province [28] 0 0
Inner Mongolia
Country [29] 0 0
China
State/province [29] 0 0
Jiangxi
Country [30] 0 0
China
State/province [30] 0 0
Liaoning
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
Colombia
State/province [34] 0 0
Antioquia
Country [35] 0 0
Colombia
State/province [35] 0 0
Cundinamarca
Country [36] 0 0
Colombia
State/province [36] 0 0
Valle Del Cauca
Country [37] 0 0
Colombia
State/province [37] 0 0
Bogota
Country [38] 0 0
Colombia
State/province [38] 0 0
Bucaramanga
Country [39] 0 0
Colombia
State/province [39] 0 0
Medellin
Country [40] 0 0
Czechia
State/province [40] 0 0
Brandys nad Labem
Country [41] 0 0
Czechia
State/province [41] 0 0
Jindrichuv Hradec III
Country [42] 0 0
Czechia
State/province [42] 0 0
Karlovy Vary
Country [43] 0 0
Czechia
State/province [43] 0 0
Novy Bor
Country [44] 0 0
Czechia
State/province [44] 0 0
Tabor
Country [45] 0 0
Denmark
State/province [45] 0 0
Herlev
Country [46] 0 0
Denmark
State/province [46] 0 0
Kobenhavn NV
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt
Country [49] 0 0
Germany
State/province [49] 0 0
Hannover
Country [50] 0 0
Germany
State/province [50] 0 0
Leipzig
Country [51] 0 0
Germany
State/province [51] 0 0
Neu-Isenburg
Country [52] 0 0
Germany
State/province [52] 0 0
Ulm
Country [53] 0 0
Guatemala
State/province [53] 0 0
Guatemala
Country [54] 0 0
Hungary
State/province [54] 0 0
Balassagyarmat
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Godollo
Country [57] 0 0
Hungary
State/province [57] 0 0
Gyula
Country [58] 0 0
Hungary
State/province [58] 0 0
Kapuvar
Country [59] 0 0
Hungary
State/province [59] 0 0
Miskolc
Country [60] 0 0
Hungary
State/province [60] 0 0
Pecs
Country [61] 0 0
Hungary
State/province [61] 0 0
Puspokladany
Country [62] 0 0
Israel
State/province [62] 0 0
Rehovot
Country [63] 0 0
Italy
State/province [63] 0 0
Firenze
Country [64] 0 0
Malaysia
State/province [64] 0 0
Kedah
Country [65] 0 0
Malaysia
State/province [65] 0 0
Perak
Country [66] 0 0
Malaysia
State/province [66] 0 0
Pulau Pinang
Country [67] 0 0
Malaysia
State/province [67] 0 0
Selangor
Country [68] 0 0
Malaysia
State/province [68] 0 0
Kuala Lumpur
Country [69] 0 0
New Zealand
State/province [69] 0 0
Auckland
Country [70] 0 0
New Zealand
State/province [70] 0 0
Rotorua
Country [71] 0 0
New Zealand
State/province [71] 0 0
Tauranga
Country [72] 0 0
Peru
State/province [72] 0 0
Lima
Country [73] 0 0
Peru
State/province [73] 0 0
Cusco
Country [74] 0 0
Poland
State/province [74] 0 0
Lubelskie
Country [75] 0 0
Poland
State/province [75] 0 0
Slaskie
Country [76] 0 0
Poland
State/province [76] 0 0
Bialystok
Country [77] 0 0
Poland
State/province [77] 0 0
Bychawa
Country [78] 0 0
Poland
State/province [78] 0 0
Katowice
Country [79] 0 0
Poland
State/province [79] 0 0
Krakow
Country [80] 0 0
Poland
State/province [80] 0 0
Lodz
Country [81] 0 0
Poland
State/province [81] 0 0
Ostrowiec Swietokrzyski
Country [82] 0 0
Poland
State/province [82] 0 0
Sochaczew
Country [83] 0 0
Poland
State/province [83] 0 0
Swidnik
Country [84] 0 0
Poland
State/province [84] 0 0
Warszawa
Country [85] 0 0
Poland
State/province [85] 0 0
Zawadzkie
Country [86] 0 0
South Africa
State/province [86] 0 0
Bloemfontein
Country [87] 0 0
South Africa
State/province [87] 0 0
Gauteng
Country [88] 0 0
South Africa
State/province [88] 0 0
Kwazulu Natal
Country [89] 0 0
South Africa
State/province [89] 0 0
Tswane
Country [90] 0 0
South Africa
State/province [90] 0 0
Western Cape
Country [91] 0 0
Turkey
State/province [91] 0 0
Gorukle
Country [92] 0 0
Turkey
State/province [92] 0 0
Adana
Country [93] 0 0
Turkey
State/province [93] 0 0
Ankara
Country [94] 0 0
Turkey
State/province [94] 0 0
Edirne
Country [95] 0 0
Turkey
State/province [95] 0 0
Istambul
Country [96] 0 0
Turkey
State/province [96] 0 0
Izmir
Country [97] 0 0
Turkey
State/province [97] 0 0
Manisa
Country [98] 0 0
Ukraine
State/province [98] 0 0
Chernihiv
Country [99] 0 0
Ukraine
State/province [99] 0 0
Chernivtsi
Country [100] 0 0
Ukraine
State/province [100] 0 0
Kherson
Country [101] 0 0
Ukraine
State/province [101] 0 0
Kiev
Country [102] 0 0
Ukraine
State/province [102] 0 0
Kyiv
Country [103] 0 0
Ukraine
State/province [103] 0 0
KYiv
Country [104] 0 0
Ukraine
State/province [104] 0 0
Lutsk
Country [105] 0 0
Ukraine
State/province [105] 0 0
Poltava
Country [106] 0 0
Ukraine
State/province [106] 0 0
Vinnytsia
Country [107] 0 0
Ukraine
State/province [107] 0 0
Zaporizhzhia
Country [108] 0 0
Ukraine
State/province [108] 0 0
Zhytomyr
Country [109] 0 0
United Kingdom
State/province [109] 0 0
East Yorkshire
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Edgbaston
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Essex
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Kent
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Middlesex
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Northamptonshire
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Warwickshire
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Belfast
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Glasgow
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Liverpool
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Llanelli
Country [120] 0 0
United Kingdom
State/province [120] 0 0
London
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Manchester
Country [122] 0 0
United Kingdom
State/province [122] 0 0
North Shields
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Rothwell
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Taunton
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Yate

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03449147