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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7264-033 | Other Identifier | Merck Protocol Number | |
| 183925 | Registry Identifier | JAPIC-CTI |
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This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic cough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefapixant 45 mg | Experimental | Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days. |
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| Placebo | Placebo Comparator | Participants will receive a film-coated placebo tablet matching gefapixant BID for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefapixant 45 mg | Drug | Gefapixant 45 mg (film-coated tablet) to be administered orally BID |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to 6 weeks |
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour | Cough frequency will be evaluated using a digital recording device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. Change from baseline in log-transformed 24-hour coughs per hour = log (24-hour coughs per hour at post-baseline) - log (24-hour coughs per hour at baseline). The denominators may be different if the recording period is actually <24 hours but ≥20 hours). |
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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 |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital ( Site 3328) | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Idaimae Minamiyojo Int Clinic ( Site 3321) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefapixant 45 mg | Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days. |
| FG001 | Placebo | Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2017 |
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Japanese adult participants with refractory or unexplained chronic cough will be randomized to 1 of 2 treatment groups: gefapixant 45 mg twice daily (BID), or placebo BID.
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| Placebo | Drug | Placebo (film-coated tablet) matching gefapixant to be administered orally BID |
|
| Baseline and Week 4 |
| Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour | Change from baseline at Week 4 in awake coughs per hour is the average hourly cough frequency (based on sound recordings) during the 24-hour monitoring period while the participant is awake. Change from baseline in log-transformed awake coughs per hour = log (awake coughs per hour at post-baseline) - log (awake coughs per hour at baseline) for the monitoring period the participant is awake. | Baseline and Week 4 |
| Sapporo |
| Hokkaido |
| 064-0804 |
| Japan |
| Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314) | Kakogawa | Hyōgo | 675-0101 | Japan |
| Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301) | Hitachi-Naka | Ibaraki | 312-0057 | Japan |
| Saiseikai Kanazawa Hospital ( Site 3337) | Kanazawa | Ishikawa-ken | 920-0353 | Japan |
| Komatsu Municipal Hospital ( Site 3308) | Komatsu | Ishikawa-ken | 923-8560 | Japan |
| Kamei Internal Medicine and Respiratory Clinic ( Site 3309) | Takamatsu | Kagawa-ken | 761-8073 | Japan |
| Yokohama City Minato Red Cross Hospital ( Site 3306) | Yokohama | Kanagawa | 231-8682 | Japan |
| Matsusaka City Hospital ( Site 3325) | Matsusaka | Mie-ken | 515-8544 | Japan |
| Nagaoka Red Cross Hospital ( Site 3307) | Nagaoka | Niigata | 940-2085 | Japan |
| Kawaguchi Respiratory Clinic ( Site 3304) | Higashiosaka | Osaka | 577-0843 | Japan |
| Fukushima Medical University Hospital ( Site 3338) | Fukushima | 960-1295 | Japan |
| Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310) | Tokyo | 101-0041 | Japan |
| Nihonbashi Medical & Allergy Clinic ( Site 3334) | Tokyo | 103-0022 | Japan |
| Fukuwa Clinic ( Site 3311) | Tokyo | 103-0027 | Japan |
| Showa University Hospital ( Site 3331) | Tokyo | 142-8666 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefapixant 45 mg | Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days. |
| BG001 | Placebo | Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days. |
| BG002 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 24-hour cough frequency | Mean | Standard Deviation | coughs/hour |
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| Awake cough frequency | 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 | Number of Participants Who Experienced an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 6 weeks |
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| Primary | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 4 weeks |
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| Secondary | Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour | Cough frequency will be evaluated using a digital recording device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. Change from baseline in log-transformed 24-hour coughs per hour = log (24-hour coughs per hour at post-baseline) - log (24-hour coughs per hour at baseline). The denominators may be different if the recording period is actually <24 hours but ≥20 hours). | All randomized participants who have taken at least one dose of study medication and provided at least one baseline and one post-baseline 24-hour cough observations during the treatment period. | Posted | Least Squares Mean | Standard Error | Coughs/hour | Baseline and Week 4 |
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| Secondary | Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour | Change from baseline at Week 4 in awake coughs per hour is the average hourly cough frequency (based on sound recordings) during the 24-hour monitoring period while the participant is awake. Change from baseline in log-transformed awake coughs per hour = log (awake coughs per hour at post-baseline) - log (awake coughs per hour at baseline) for the monitoring period the participant is awake. | All randomized participants who have taken at least one dose of study medication and provided at least one baseline and one post-baseline awake cough observations during the treatment period. | Posted | Least Squares Mean | Standard Error | Coughs/hour | Baseline and Week 4 |
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Up to 6 weeks
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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 | Gefapixant 45 mg | Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days. | 0 | 11 | 0 | 11 | 9 | 11 |
| EG001 | Placebo | Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days. | 0 | 12 | 0 | 12 | 2 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Oral discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-80-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jun 25, 2019 |
| Prot_SAP_000.pdf |
| 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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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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