Trial · NCT03569033

Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

NCT03569033, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2019-12-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013). Trials, record NCT03569033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03569033

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
NCT number: NCT03569033
Status: Terminated
Phases: Phase 2
Enrollment: 46 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Acute Cough
Interventions: Gefapixant, Placebo
First posted: 2018-06-26
Last updated: 2019-12-10
Other registries' IDs: eudract:2017-000472-28
Results first posted: 2019-12-10
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Awake Coughs Per Hour on Day 3	Day 3	Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.
Secondary	Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3	Baseline and 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.
Secondary	Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3	Baseline and 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.
Secondary	Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3	Baseline and 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.
Secondary	Percentage of Participants Who Experienced One or More Adverse Events (AEs)	Up to 21 days	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.
Secondary	Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)	Up to Day 7	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Awake Coughs Per Hour on Day 3	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)	Coughs per hour	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3	Baseline and 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	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3	Baseline and 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	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3	Baseline and 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	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Experienced One or More Adverse Events (AEs)	Up to 21 days	All randomized participants who received at least 1 dose of study treatment	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)	Up to Day 7	All randomized participants who received at least 1 dose of study treatment	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Awake Coughs Per Hour on Day 3	Gefapixant 45 mg BID	2.38	95% Confidence Interval 1.01 to 3.75	Coughs per hour
Awake Coughs Per Hour on Day 3	Placebo BID	2.70	95% Confidence Interval 1.21 to 4.19	Coughs per hour
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3	Gefapixant 45 mg BID	6.07	95% Confidence Interval 1.79 to 10.35	Scores on a scale
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3	Placebo BID	5.08	95% Confidence Interval 0.39 to 9.78	Scores on a scale
Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3	Gefapixant 45 mg BID	2.71	95% Confidence Interval 0.46 to 4.97	Scores on a scale
Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3	Placebo BID	1.91	95% Confidence Interval -0.55 to 4.38	Scores on a scale
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3	Gefapixant 45 mg BID	-0.26	95% Confidence Interval -0.51 to -0.01	Scores on a scale
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3	Placebo BID	-0.35	95% Confidence Interval -0.62 to -0.08	Scores on a scale
Percentage of Participants Who Experienced One or More Adverse Events (AEs)	Gefapixant 45 mg BID	100		Percentage of participants
Percentage of Participants Who Experienced One or More Adverse Events (AEs)	Placebo BID	95.7		Percentage of participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gefapixant 45 mg BID	23
Overall Study	STARTED	Placebo BID	23
Overall Study	COMPLETED	Gefapixant 45 mg BID	23
Overall Study	COMPLETED	Placebo BID	23
Overall Study	NOT COMPLETED	Gefapixant 45 mg BID	0
Overall Study	NOT COMPLETED	Placebo BID	0

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	MK-7264 45 mg BID	0	23	0
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	23	2
other	Nausea	Gastrointestinal disorders	MK-7264 45 mg BID	3	23	4
other	Nausea	Gastrointestinal disorders	Placebo	0	23	0
other	Salivary hypersecretion	Gastrointestinal disorders	MK-7264 45 mg BID	2	23	2
other	Salivary hypersecretion	Gastrointestinal disorders	Placebo	0	23	0
other	Medical device site erythema	General disorders	MK-7264 45 mg BID	16	23	16
other	Medical device site erythema	General disorders	Placebo	17	23	17
other	Upper respiratory tract infection	Infections and infestations	MK-7264 45 mg BID	20	23	20
other	Upper respiratory tract infection	Infections and infestations	Placebo	21	23	22

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MK-7264 45 mg BID	0	23
Total, all-cause mortality	Placebo	0	23
Total, other adverse events	MK-7264 45 mg BID	23	23
Total, other adverse events	Placebo	22	23
Total, serious adverse events	MK-7264 45 mg BID	0	23
Total, serious adverse events	Placebo	0	23

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35969360	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MK-7264 45 mg BID vs Placebo: deaths from any cause	Trial comparisons
MK-7264 45 mg BID vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03569033

GET https://conductscience.org/api/trials/v1/NCT03569033/registered

API reference For AI assistants