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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Cough

In brief

The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

Key facts

Study ID

NCT03449134

Run by

Merck Sharp & Dohme LLC

People needed

732

Starts

2018-03-14

Expected to finish

2020-08-17

Last updated by the study team

2021-06-16

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
• Female participants are eligible if not pregnant, not breastfeeding, and either not of childbearing potential, or agree 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
• 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

Where it is running

• Medical Research of AZ ( Site 0060) — Scottsdale, Arizona, United States
• Biosolutions Clinical Research Center ( Site 0070) — La Mesa, California, United States
• Center for Clinical Trials, LLC ( Site 0059) — Paramount, California, United States
• Sher Allergy Specialists/Center For Cough ( Site 0078) — Largo, Florida, United States
• Well Pharma Medical Research, Corp. ( Site 0093) — Miami, Florida, United States
• Florida Pulmonary Research Institute, LLC ( Site 0019) — Winter Park, Florida, United States
• Midwest Allergy Sinus Asthma, SC ( Site 0081) — Normal, Illinois, United States
• Cotton-O'Neil Clinical Research Center ( Site 0052) — Topeka, Kansas, United States
• BreatheAmerica Inc ( Site 0048) — Shreveport, Louisiana, United States
• Clinical Research Institute LLC ( Site 0004) — Minneapolis, Minnesota, United States
• The Center for Pharmaceutical Research PC ( Site 0016) — Kansas City, Missouri, United States
• American Health Research ( Site 0082) — Charlotte, North Carolina, United States
• Clinical Research of Gastonia ( Site 0043) — Gastonia, North Carolina, United States
• Bernstein Clinical Research Center, LLC ( Site 0005) — Cincinnati, Ohio, United States
• Vital Prospects Clinical Research Institute, PC ( Site 0037) — Tulsa, Oklahoma, United States
• Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075) — East Providence, Rhode Island, United States
• Sirius Clinical Research, LLC ( Site 0102) — Austin, Texas, United States
• Pharmaceutical Research & Consulting, Inc. ( Site 0029) — Dallas, Texas, United States
• Mainland Medical Research Institute ( Site 0003) — Dickinson, Texas, United States
• Diagnostics Research Group ( Site 0035) — San Antonio, Texas, United States
• Allergy & Asthma Center ( Site 0001) — Waco, Texas, United States
• Intermountain Clinical Research ( Site 0033) — Draper, Utah, United States
• Charlottesville Medical Research Center, LLC ( Site 0006) — Charlottesville, Virginia, United States
• Pulmonary Associates of Richmond Inc. ( Site 0101) — Richmond, Virginia, United States
• Research Solutions of Arizona PC ( Site 0036) — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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