Status:
COMPLETED
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Cough
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the mai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
1317 Patients enrolled
Trial Details
Trial ID
NCT03449147
Start Date
March 15 2018
End Date
October 30 2020
Last Update
September 2 2021
Active Locations (171)
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1
Phoenix Medical Group ( Site 0022)
Peoria, Arizona, United States, 85381
2
Pulmonary Associates, PA ( Site 0063)
Phoenix, Arizona, United States, 85006
3
Clinical Research Consortium ( Site 0088)
Tempe, Arizona, United States, 85283
4
Allergy & Asthma Associates of SCV Research Center ( Site 0064)
San Jose, California, United States, 95117