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

Use our guide to learn which trials are right for you!

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.

This study will have a main 24-week treatment period and a 28-week extension period of
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
Ypsilanti, Michigan 48197
Phone: 734-528-0477
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials
3550 Jerome Avenue
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Albuquerque, New Mexico
Phone: 505-224-7407
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Bangor, Maine 04401
Phone: 207-947-8658
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Bellingham, Washington 98225
Phone: 360-733-5733
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
Bethesda, Maryland 20814
Phone: 301-907-3476
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Charleston, South Carolina 29406
Phone: 843-572-8545
?
mi
from
Charleston, SC
Click here to add this to my saved trials
232 South Woods Mill Road
Chesterfield, Missouri 63017
Phone: 314-682-3653
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
1653 W. Congress Parkway
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbia, Missouri 65201
Phone: 573-882-2549
?
mi
from
Columbia, MO
Click here to add this to my saved trials
Columbus, Ohio 43215
Phone: 614-487-2560
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Edina, Minnesota 55435
Phone: 952-852-5268
?
mi
from
Edina, MN
Click here to add this to my saved trials
Flossmoor, Illinois 60422
Phone: 708-388-2245
?
mi
from
Flossmoor, IL
Click here to add this to my saved trials
Fort Mitchell, Kentucky 41017
Phone: 859-371-3798
?
mi
from
Fort Mitchell, KY
Click here to add this to my saved trials
Greensboro, North Carolina 27403
Phone: 336-323-5276
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29406
Phone: 8646273800221
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Las Vegas, Nevada 89119
Phone: 702-545-6840
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Maroubra, New South Wales 2035
Phone: +61293143400
?
mi
from
Maroubra,
Click here to add this to my saved trials
Medford, Oregon 97504
Phone: 541-494-3219
?
mi
from
Medford, OR
Click here to add this to my saved trials
Ocean City, New Jersey 07712
Phone: 732-695-2555
?
mi
from
Ocean City, NJ
Click here to add this to my saved trials
Omaha, Nebraska 68130
Phone: 402-280-4142
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Peoria, Arizona 85381
Phone: 623-583-6542
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85006
Phone: 602-258-4951
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Portland, Oregon 97216
Phone: 503-238-6233
?
mi
from
Portland, OR
Click here to add this to my saved trials
3100 Duraleigh Rd
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...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia
Phone: 804-308-8659
?
mi
from
Richmond, VA
Click here to add this to my saved trials
200 First Street SW
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...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Rock Hill, South Carolina 29732
Phone: 803-746-4542
?
mi
from
Rock Hill, SC
Click here to add this to my saved trials
San Jose, California 95117
Phone: 408-553-0709
?
mi
from
San Jose, CA
Click here to add this to my saved trials
Spokane, Washington 99202
Phone: 509-343-3710
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Stockbridge, Georgia 30281
Phone: 770-996-5354
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
Sweetwater, Florida 33172
Phone: 305-592-4692
?
mi
from
Sweetwater, FL
Click here to add this to my saved trials
314 Martin Luther King Junior Way
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...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tempe, Arizona 85283
Phone: 702-545-6766
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Warwick, Rhode Island 02886
Phone: 401-681-4960
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Woodbury, Minnesota 55125
Phone: 952-852-5268
?
mi
from
Woodbury, MN
Click here to add this to my saved trials