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

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