Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
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|ClinicalTrials.gov Identifier: NCT04193202|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2019
Last Update Posted : July 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cough||Drug: Gefapixant Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||414 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough|
|Actual Study Start Date :||May 21, 2020|
|Estimated Primary Completion Date :||November 9, 2021|
|Estimated Study Completion Date :||November 9, 2021|
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Administered twice daily as an oral tablet of 45 mg
Other Name: MK-7264
Placebo Comparator: Placebo
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Administered twice daily as a placebo oral tablet matching gefapixant
- Change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12 [ Time Frame: Baseline, Week 12 ]Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score will be calculated.
- Change from baseline in the Cough Severity Visual Analog Scale (VAS) score at Week 12 [ Time Frame: Baseline, Week 12 ]Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score will be calculated.
- Percentage of participants with one or more adverse events (AEs) [ Time Frame: Up to ~Week 14 ]An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs will be calculated.
- Percentage of participants who discontinue study drug due to an AE [ Time Frame: Up to Week 12 ]An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193202
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|