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| ID | Type | Description | Link |
|---|---|---|---|
| AF219-021 | Other Identifier | Afferent Pharmaceuticals | |
| MK-7264-021 | Other Identifier | Merck Protocol Number |
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This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefapixant 15 mg twice daily | Experimental | Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
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| Gefapixant 30 mg twice daily | Experimental | Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
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| Gefapixant 50 mg twice daily | Experimental | One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks |
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| Placebo to match gefapixant | Experimental | Matching placebo tablets administered by mouth twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefapixant | Drug | Gefapixant tablets administered by mouth twice daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment. | Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency. | Baseline and Week 8 (Day 56) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Afferent Investigative Site | Mission Viejo | California | United States | |||
| Afferent Investigative Site |
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Male and female participants with treatment-refractory chronic cough were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefapixant 15 mg Twice Daily | Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
| FG001 | Gefapixant 30 mg Twice Daily | Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo (for gefapixant) | Drug | Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks |
|
| San Jose |
| California |
| United States |
| Afferent Investigative Site | Colorado Springs | Colorado | United States |
| Afferent Investigative Site | Largo | Florida | United States |
| Afferent Investigative Site | Charlotte | North Carolina | United States |
| Afferent Investigative Site | Tulsa | Oklahoma | United States |
| Afferent Investigative Site | Dallas | Texas | United States |
| Afferent Investigative Site | San Antonio | Texas | United States |
| Afferent Investigative Site | Bellevue | Washington | United States |
| Afferent Investigative Site | Greenfield | Wisconsin | United States |
| FG002 | Gefapixant 50 mg Twice Daily | One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks |
| FG003 | Placebo to Match Gefapixant | Matching placebo tablets administered by mouth twice daily for 8 weeks |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants who had received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefapixant 15 mg Twice Daily | Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
| BG001 | Gefapixant 30 mg Twice Daily | Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
| BG002 | Gefapixant 50 mg Twice Daily | One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks |
| BG003 | Placebo to Match Gefapixant | Matching placebo tablets administered by mouth twice daily for 8 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Cough Frequency | Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0. The cough frequency is the coughs/hr over the 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. | All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation. | Mean | Standard Deviation | Coughs/hour |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment. | Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency. | All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation. | Posted | Mean | Standard Deviation | Coughs/hour | Baseline and Week 8 (Day 56) |
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Up to 14 days after Day 57 (up to 71 days)
The population analyzed was all randomized participants who had received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo tablets administered by mouth twice daily for 8 weeks | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | Gefapixant 15 mg | Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | Gefapixant 30 mg | Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks | 0 | 5 | 1 | 5 | 4 | 5 |
| EG003 | Gefapixant 50 mg | One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks | 0 | 6 | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Stress fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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The results obtained during the course of this study will be kept confidential and will not be disclosed in whole or in part to others or used for any purpose other than reviewing or performing the study without the written consent of the Sponsor. No data collected as part of this study will be utilized in any written work, including publications, without the written consent of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000597312 | Gefapixant |
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LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate. |
| LSM Difference |
| -0.71 |
| 2-Sided |
| 95 |
| -2.34 |
| 0.92 |
Gefapixant minus Placebo |
| Other |
| LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate. | LSM Difference | -1.35 | 2-Sided | 95 | -2.99 | 0.30 | Gefapixant minus Placebo | Other |
| Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate. | Percentage Change | -42.6 | 2-Sided | 95 | -87.5 | 162.3 | 100 x [(Exponent of LSM Difference) minus 1] | Other |
| Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate. | Percentage Change | -50.8 | 2-Sided | 95 | -90.3 | 151.1 | 100 x [(Exponent of LSM Difference) minus 1] | Other |
| Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate. | Percentage Change | -74.0 | 2-Sided | 95 | -95.0 | 34.7 | 100 x [(Exponent of LSM Difference) minus 1] | Other |