A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Cough

In brief

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

Key facts

Study ID

NCT03449147

Run by

Merck Sharp & Dohme LLC

People needed

1317

Starts

2018-03-15

Expected to finish

2020-10-30

Last updated by the study team

2021-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates, PA ( Site 0063) — Phoenix, Arizona, United States
• Clinical Research Consortium ( Site 0088) — Tempe, Arizona, United States
• Allergy & Asthma Associates of SCV Research Center ( Site 0064) — San Jose, California, United States
• Lenus Research & Medical Group Llc ( Site 0075) — Sweetwater, Florida, United States
• Atlanta Allergy & Asthma Clinic PA ( Site 0029) — Stockbridge, Georgia, United States
• Rush University Medical Center ( Site 0103) — Chicago, Illinois, United States
• Healthcare Research Network LLC ( Site 0093) — Flossmoor, Illinois, United States
• Abraham Research, PLLC ( Site 0107) — Fort Mitchell, Kentucky, United States
• Paul A. Shapero, MD ( Site 0104) — Bangor, Maine, United States
• Bethesda Allergy Asthma and Research Center LLC ( Site 0019) — Bethesda, Maryland, United States
• Respiratory Medicine Research Institute of Michigan, PLC ( Site 0034) — Ypsilanti, Michigan, United States
• Minnesota Lung Center ( Site 0108) — Edina, Minnesota, United States
• Mayo Clinic - Rochester ( Site 0006) — Rochester, Minnesota, United States
• Minnesota Lung Center ( Site 0041) — Woodbury, Minnesota, United States
• The Lung Research Center ( Site 0072) — Chesterfield, Missouri, United States
• University of Missouri ENT & Allergy Center ( Site 0066) — Columbia, Missouri, United States
• CHI Health Creighton University Medical Center ( Site 0024) — Omaha, Nebraska, United States
• Clinical Research Consortium ( Site 0050) — Las Vegas, Nevada, United States
• Atlantic Research Center LLC ( Site 0012) — Ocean City, New Jersey, United States
• Albuquerque Clinical Trials ( Site 0039) — Albuquerque, New Mexico, United States
• Montefiore Medical Center ( Site 0098) — The Bronx, New York, United States
• Wake Research Associates, LLC ( Site 0058) — Raleigh, North Carolina, United States
• Remington-Davis, Inc. ( Site 0082) — Columbus, Ohio, United States
• Clinical Research Institute of Southern Oregon, PC ( Site 0099) — Medford, Oregon, United States
• Phoenix Medical Group ( Site 0022) — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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