Chronic Cough MedDRA version: 21.1 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 100000004855
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has a 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. 2. Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for =65 years) yes F.1.3.1 Number of subjects for this age range 207
Exclusion criteria
Exclusion criteria: 1. Is a current smoker. 2. Has given up smoking within 12 months of Screening/Visit 1. 3. Is a former smoker with a smoking history greater than 20 pack-years (eg, 1 pack [20 cigarettes] per day for 20 years). 4. Has a FEV1/ FVC ratio 200% of the upper limit of normal, or bilirubin >150% of the upper limit of normal. b. hemoglobin <10 g/dL, WBC count <2500 mm3 (<2.5 × 1000/µL), neutrophil count <1500 mm3 (<1.5 × 1000/µL), platelet count <100 × 1000/mm3 (<100 × 1000/uL). For any of the above listed laboratory assessments, 1 repeat measurement will be allowed at the investigator’s discretion, before being considered a screen failure. 18. Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study. 19. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the efficacy of gefapixant (MK-7264) in improving cough specific quality of life, measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12;Secondary Objective: 1. To evaluate the efficacy of gefapixant in improving self-rated cough severity, measured as change from baseline in the Cough Severity Visual Analog Scale (VAS) score at Week 12 2. To evaluate the safety and tolerability of gefapixant compared to placebo in percent of participants with adverse events (AEs) ;Primary end point(s): 1. Change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12;Timepoint(s) of evaluation of this end point: 1. Baseline, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in the Cough Severity Visual Analog Scale (VAS) score at Week 12 2. Percentage of participants with one or more adverse events (AEs) 3. Percentage of participants who discontinue study drug due to an AE ;Timepoint(s) of evaluation of this end point: 1. Baseline, Week 12 2. Up to ~Week 14 3. Up to Week 12 | — |
Countries
Canada, Germany, Guatemala, Korea, Republic of, Peru, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trial Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Outcome results
None listed