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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7264-013 | Other Identifier | Merck Protocol Number | |
| 2017-000472-28 | EudraCT Number |
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The data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.
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The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefapixant 45 mg BID | Experimental | Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days. |
|
| Placebo BID | Placebo Comparator | Participants will receive a matching placebo tablet BID for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefapixant | Drug | Gefapixant 45 mg will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Awake Coughs Per Hour on Day 3 | Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAKâ„¢ cough monitor) on Day 3. | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3 | The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3. | Baseline and Day 3 |
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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 |
|---|---|---|---|---|---|---|
| Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003) | London | E1 2AX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35969360 | Derived | Smith JA, Kitt MM, Bell A, Noulin N, Tzontcheva A, Seng MM, Lu S. Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial. Pulm Ther. 2022 Sep;8(3):297-310. doi: 10.1007/s41030-022-00193-w. Epub 2022 Aug 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefapixant 45 mg BID | Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days. |
| FG001 | Placebo BID | Participants received a matching placebo tablet BID for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefapixant 45 mg BID | Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days. |
| BG001 | Placebo BID | Participants received a matching placebo tablet BID for 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Awake Coughs Per Hour on Day 3 | Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAKâ„¢ cough monitor) on Day 3. | All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with human rhinovirus type 16 (HRV-16) | Posted | Least Squares Mean | 95% Confidence Interval | Coughs per hour | Day 3 |
|
Up to 21 days
All randomized participants who received at least 1 dose of study treatment
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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 | MK-7264 45 mg BID | Participants received a gefapixant 45 mg tablet BID for 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
This study was terminated because the data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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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 | Oct 13, 2017 | Oct 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000597312 | Gefapixant |
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| Placebo | Drug | Placebo tablet matching gefapixant will be administered orally. |
|
| Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3 | The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3. | Baseline and Day 3 |
| Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3 | The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3. | Baseline and Day 3 |
| Percentage of Participants Who Experienced One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 21 days |
| Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to Day 7 |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3 | The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3. | All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16 | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Day 3 |
|
|
|
|
| Secondary | Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3 | The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3. | All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16 | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Day 3 |
|
|
|
|
| Secondary | Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3 | The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3. | All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16 | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Day 3 |
|
|
|
|
| Secondary | Percentage of Participants Who Experienced One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | All randomized participants who received at least 1 dose of study treatment | Posted | Number | Percentage of participants | Up to 21 days |
|
|
|
| Secondary | Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | All randomized participants who received at least 1 dose of study treatment | Posted | Number | Percentage of participants | Up to Day 7 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 23 |
| 23 |
| EG001 | Placebo | Participants received a matching placebo tablet BID for 7 days. | 0 | 23 | 0 | 23 | 22 | 23 |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
The sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.