Status:
COMPLETED
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Cough
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at least one dose of...
Detailed Description
This study will have a main 24-week treatment period and a 28-week extension period of treatment. Participants at selected sites and countries who complete the main and extension study periods may con...
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 or is currently participating in or has participated in an interventional clinical study
Key Trial Info
Start Date :
May 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04525885
Start Date
May 17 2019
End Date
September 15 2022
Last Update
January 12 2024
Active Locations (8)
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1
The First Affiliated Hospital of Fujian Medical University ( Site 5017)
Fuzhou, Fujian, China, 350005
2
The First Affiliated Hospital of Guangzhou Medical University ( Site 5000)
Guangzhou, Guangdong, China, 510120
3
Inner Mongolia Autonomous Region Hospital ( Site 5018)
Hohhot, Inner Mongolia, China, 010017
4
The First Affiliated Hospital of Nanchang University ( Site 5012)
Nanchang, Jiangxi, China, 330006