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

• Status: Active, not recruiting
• Trial end date: 2021-11-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Chest radiograph or computerized topography (CT) scan of the thorax performed after the onset of cough symptoms but before the diagnosis of chronic cough require consultation with the Sponsor to determine if acceptable for inclusion in study

• 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

Exclusion Criteria:

• 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