Trial Outcomes & Findings for Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033) (NCT NCT03482713)

Last Updated: 2019-10-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 6 weeks

Results posted on

2019-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Gefapixant 45 mg Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.	Placebo Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefapixant 45 mg n=11 Participants Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.	Placebo n=12 Participants Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.	Total n=23 Participants Total of all reporting groups
Age, Continuous	54.5 Years STANDARD_DEVIATION 15.7 • n=5 Participants	57.2 Years STANDARD_DEVIATION 11.7 • n=7 Participants	55.9 Years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
24-hour cough frequency	40.1 coughs/hour STANDARD_DEVIATION 86.7 • n=5 Participants	22.9 coughs/hour STANDARD_DEVIATION 20.5 • n=7 Participants	31.1 coughs/hour STANDARD_DEVIATION 60.9 • n=5 Participants
Awake cough frequency	49.0 coughs/hour STANDARD_DEVIATION 103.0 • n=5 Participants	27.3 coughs/hour STANDARD_DEVIATION 21.0 • n=7 Participants	37.7 coughs/hour STANDARD_DEVIATION 71.9 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: All randomized participants who received at least one dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg n=11 Participants Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.	Placebo n=12 Participants Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
Number of Participants Who Experienced an Adverse Event	9 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: All randomized participants who received at least one dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg n=11 Participants Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.	Placebo n=12 Participants Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg n=11 Participants Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.	Placebo n=12 Participants Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour	-0.23 Coughs/hour Standard Error 0.39	-1.02 Coughs/hour Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg n=11 Participants Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.	Placebo n=12 Participants Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour	-0.20 Coughs/hour Standard Error 0.38	-0.97 Coughs/hour Standard Error 0.37

Adverse Events

Gefapixant 45 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gefapixant 45 mg n=11 participants at risk Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.	Placebo n=12 participants at risk Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/11 • Up to 6 weeks	8.3% 1/12 • Number of events 1 • Up to 6 weeks
Cardiac disorders Palpitations	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/11 • Up to 6 weeks	8.3% 1/12 • Number of events 1 • Up to 6 weeks
Gastrointestinal disorders Gastritis	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Gastrointestinal disorders Oral discomfort	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Gastrointestinal disorders Paraesthesia oral	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Gastrointestinal disorders Toothache	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Infections and infestations Nasopharyngitis	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Infections and infestations Otitis externa	0.00% 0/11 • Up to 6 weeks	8.3% 1/12 • Number of events 1 • Up to 6 weeks
Infections and infestations Pneumonia	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Nervous system disorders Dysgeusia	63.6% 7/11 • Number of events 7 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/11 • Up to 6 weeks	8.3% 1/12 • Number of events 1 • Up to 6 weeks
Skin and subcutaneous tissue disorders Dermatitis contact	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Skin and subcutaneous tissue disorders Drug eruption	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 1 • Up to 6 weeks	0.00% 0/12 • Up to 6 weeks

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-80-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.
Publication restrictions are in place

Restriction type: OTHER