A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/13/2019 |
Start Date: | March 15, 2018 |
End Date: | January 8, 2021 |
Contact: | Toll Free Number |
Email: | Trialsites@merck.com |
Phone: | 1-888-577-8839 |
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)
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.
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.
This study will have a main 24-week treatment period and a 28-week extension period of
treatment.
treatment.
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)
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
We found this trial at
36
sites
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Phone: 929-263-3262
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-8701
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Columbia, Missouri 65201
Phone: 573-882-2549
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
Raleigh, North Carolina 27612
(919) 781-2514
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-9259
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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San Jose, California 95117
Phone: 408-553-0709
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 403-5200
Phone: 253-403-0366
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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Ypsilanti, Michigan 48197
Phone: 734-528-0477
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