Phase 3 Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:March 14, 2018
End Date:July 10, 2020
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 (PN027)

The primary objective of this study was to evaluate the efficacy of gefapixant in reducing
cough frequency as measured over a 24-hour period at Week 12.

The study had a Screening period (minimum of 7 days and up to approximately 14 days) to
determine participant inclusion, a Baseline visit including 24 hours of objective measurement
of cough. The study had two treatment periods (a main 12-week treatment period and a 40-week
extension period), and a 14-day follow-up period.

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

- Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio
<60%

- 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) <30mL/min/1.73 m^2 at Screening OR
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 systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg at
Screening

- 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

- Had significantly abnormal laboratory tests at Screening
We found this trial at
28
sites
Williamsburg, Virginia 23188
Phone: 757-707-3999
?
mi
from
Williamsburg, VA
Click here to add this to my saved trials
7000 SW 62 Ave.
Miami, Florida 33143
305-284-8483
Phone: 3056654818208
?
mi
from
Miami, FL
Click here to add this to my saved trials
4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
Phone: 785-354-9591
?
mi
from
Topeka, KS
Click here to add this to my saved trials
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
Phone: 9183924550207
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Austin, Texas 78759
Phone: 512-345-8900
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Caba,
Click here to add this to my saved trials
Charlotte, North Carolina 28207
Phone: 704-926-8042
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22911
Phone: 434-817-2442
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45231
Phone: 513-354-1746
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Dallas, Texas 75231
Phone: 214-361-5555
?
mi
from
Dallas, TX
Click here to add this to my saved trials
6801 Emmett F Lowry Expressway
Dickinson, Texas 77539
Phone: 281-337-6005
?
mi
from
Dickinson, TX
Click here to add this to my saved trials
Draper, Utah 84020
Phone: 801-553-2379
?
mi
from
Draper, UT
Click here to add this to my saved trials
East Providence, Rhode Island 02914
Phone: 401-331-8426
?
mi
from
East Providence, RI
Click here to add this to my saved trials
Gastonia, North Carolina 28054
Phone: 704-675-7144
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
Kansas City, Missouri 64114
Phone: 816-943-0770
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 619-229-2355
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
11200 Seminole Boulevard
Largo, Florida 33778
Phone: 727-397-8557
?
mi
from
Largo, FL
Click here to add this to my saved trials
555 East Plaza Circle
Litchfield Park, Arizona 85340
Phone: 623-512-4340
?
mi
from
Litchfield Park, AZ
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
Phone: 7637441140320
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
2010 Jacobssen Drive
Normal, Illinois 61761
Phone: 309-452-0995
?
mi
from
Normal, IL
Click here to add this to my saved trials
Paramount, California 90723
Phone: 562-633-5101
?
mi
from
Paramount, CA
Click here to add this to my saved trials
Richmond, Virginia 23225
Phone: 804-323-7002
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Richmond, Virginia 23294
Phone: 8043722133X28
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
Phone: 480-675-8982
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Shreveport, Louisiana 71106
Phone: 318-562-2536
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Waco, Texas 76712
Phone: 254-751-1144
?
mi
from
Waco, TX
Click here to add this to my saved trials
Winter Park, Florida 32789
Phone: 407-740-8078
?
mi
from
Winter Park, FL
Click here to add this to my saved trials