Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Cough

In brief

The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration \>8 weeks after onset of cough symptoms) for \<12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.

Key facts

Study ID

NCT04193202

Run by

Merck Sharp & Dohme LLC

People needed

419

Starts

2020-05-21

Expected to finish

2021-11-03

Last updated by the study team

2023-05-16

Who can join

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

You may qualify if…

• Chest radiograph or CT thorax (within 1 year 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 subinvestigator
• Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (<14 months after onset of cough symptoms)
• Has a diagnosis of refractory chronic cough or unexplained chronic cough
• Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance

You may not qualify if…

• Is a current smoker
• Has given up smoking within 12 months of screening
• Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
• Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
• Has a history of chronic bronchitis, defined as cough that produces >1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
• Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
• Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
• Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
• Has a known allergy to gefapixant or its excipients
• Has donated or lost ≥1 unit (\~300 mL) of blood within 8 weeks prior to first dose of gefapixant
• Has previously received gefapixant
• Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study

Where it is running

• Center for Clinical Trials, LLC ( Site 0035) — Paramount, California, United States
• Springfield Clinic, LLP ( Site 0018) — Springfield, Illinois, United States
• Chesapeake Clinical Research, Inc ( Site 0037) — White Marsh, Maryland, United States
• Albuquerque Clinical Trials ( Site 0030) — Albuquerque, New Mexico, United States
• Montefiore Einstein Center ( Site 0022) — The Bronx, New York, United States
• American Health Research ( Site 0047) — Charlotte, North Carolina, United States
• Clinical Research Institute of Southern Oregon, PC ( Site 0028) — Medford, Oregon, United States
• Northwest Research Center ( Site 0039) — Portland, Oregon, United States
• AAPRI Clinical Research Institute ( Site 0051) — Lincoln, Rhode Island, United States
• Allergic Disease and Asthma Center ( Site 0027) — Greenville, South Carolina, United States
• Diagnostics Research Group ( Site 0021) — San Antonio, Texas, United States
• Allergy & Asthma Center ( Site 0001) — Waco, Texas, United States
• Tidewater Physician Multispecialty Group, PC ( Site 0048) — Williamsburg, Virginia, United States
• Bellingham Asthma & Allergy ( Site 0011) — Bellingham, Washington, United States
• Recherche GCP Research ( Site 0802) — Montreal, Quebec, Canada
• Diex Recherche Quebec Inc ( Site 0805) — Québec, Quebec, Canada
• Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800) — Québec, Quebec, Canada
• Fundacion Centro de Investigacion Clinica CIC ( Site 0401) — Medellín, Antioquia, Colombia
• Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408) — Medellín, Antioquia, Colombia
• MedPlus Medicina Prepagada S.A. ( Site 0402) — Bogotá, Bogota D.C., Colombia
• Centro Especializado en Enfermedades Pulmonares. ( Site 0410) — Bogotá, Bogota D.C., Colombia
• Healthy Medical Center S.A.S ( Site 0404) — Zipaquirá, Cundinamarca, Colombia
• Instituto Neumologico del Oriente ( Site 0403) — Floridablanca, Santander Department, Colombia
• Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910) — Marburg, Hesse, Germany
• Pulmonary Associates, PA ( Site 0016) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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