CompletedNCT03482713Updated Oct 17, 2019Results posted

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

A Phase 2 interventional study of Gefapixant 45 mg and Placebo in Chronic Cough, sponsored by Merck Sharp & Dohme LLC. Completed at 16 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-10-17.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 23
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

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.

Conditions studied

Chronic Cough

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Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator.
Has had chronic cough for ≥ 1 year and a diagnosis of refractory chronic cough or unexplained chronic cough.
For female participants, is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Exclusion criteria

Exclusion Criteria:

Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with a pack-year history >20 pack-years
Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status
Has a history of chronic bronchitis
Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
Has a history of malignancy ≤5 years
Has a screening systolic blood pressure >160 millimeters of mercury (mmHg) or a diastolic blood pressure >90 mm Hg
Has a history of cutaneous adverse drug reaction to sulfonamides with or without systemic symptoms or history of anaphylaxis to sulfonamides
Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
Has a known allergy/sensitivity or contraindication to gefapixant
Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 23 participants (actual)

Study arms

Experimental
Gefapixant 45 mg
Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days.
Drug: Gefapixant 45 mg
Placebo comparator
Placebo
Participants will receive a film-coated placebo tablet matching gefapixant BID for 28 days.
Drug: Placebo

Interventions

DrugGefapixant 45 mg
Gefapixant 45 mg (film-coated tablet) to be administered orally BID
Also known as: MK-7264
DrugPlacebo
Placebo (film-coated tablet) matching gefapixant to be administered orally BID

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Up to 4 weeks

Secondary outcomes

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).
Time frame: 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.
Time frame: Baseline and Week 4

Results

Posted Jul 5, 2019

Participant flow

Participant flow — Overall Study
Milestone	Gefapixant 45 mg	Placebo
Started	11	12
Completed	11	12
Not completed	0	0

Outcome measures

PrimaryNumber 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.

Time frame:: Up to 6 weeks
Reported as:: Count of participants · Participants

Number of Participants Who Experienced an Adverse Event
Participants	Gefapixant 45 mg	Placebo
Number of Participants Who Experienced an Adverse Event	9	2

PrimaryNumber 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.

Time frame:: Up to 4 weeks
Reported as:: Count of participants · Participants

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
Participants	Gefapixant 45 mg	Placebo
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event	1	0

SecondaryChange 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).

Time frame:: Baseline and Week 4
Reported as:: Least squares mean · Coughs/hour

Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour
Coughs/hour	Gefapixant 45 mg	Placebo
Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour	-0.23 ± 0.39	-1.02 ± 0.38

Statistical analysis

Gefapixant 45 mg vs Placebo · Difference in least squares means: 0.79 · 95% CI -0.34 to 1.93Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.

SecondaryChange 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.

Time frame:: Baseline and Week 4
Reported as:: Least squares mean · Coughs/hour

Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour
Coughs/hour	Gefapixant 45 mg	Placebo
Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour	-0.20 ± 0.38	-0.97 ± 0.37

Statistical analysis

Gefapixant 45 mg vs Placebo · Difference least squares mean: 0.76 · 95% CI -0.35 to 1.88Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.

Adverse events

Collected over Up to 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Gefapixant 45 mg	0/11 (0%)	0/11 (0%)	9/11 (81.8%)
Placebo	0/12 (0%)	0/12 (0%)	2/12 (16.7%)

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Gefapixant 45 mg	Placebo
DysgeusiaNervous system disorders	7/11	0/12
PalpitationsCardiac disorders	1/11	0/12
GastritisGastrointestinal disorders	1/11	0/12
Oral discomfortGastrointestinal disorders	1/11	0/12
Paraesthesia oralGastrointestinal disorders	1/11	0/12
ToothacheGastrointestinal disorders	1/11	0/12
NasopharyngitisInfections and infestations	1/11	0/12
PneumoniaInfections and infestations	1/11	0/12
Dermatitis contactSkin and subcutaneous tissue disorders	1/11	0/12
Drug eruptionSkin and subcutaneous tissue disorders	1/11	0/12

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Gefapixant 45 mg	Placebo	Total
Mean	54.5 ± 15.7	57.2 ± 11.7	55.9 ± 13.5

Sex: Female, Male
Sex: Female, Male(Participants)	Gefapixant 45 mg	Placebo	Total
Female	8	9	17
Male	3	3	6

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Gefapixant 45 mg	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	11	12	23
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	0	0	0
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Gefapixant 45 mg	Placebo	Total
Japan	11	12	23

24-hour cough frequency
24-hour cough frequency(coughs/hour)	Gefapixant 45 mg	Placebo	Total
Mean	40.1 ± 86.7	22.9 ± 20.5	31.1 ± 60.9

Awake cough frequency
Awake cough frequency(coughs/hour)	Gefapixant 45 mg	Placebo	Total
Mean	49.0 ± 103.0	27.3 ± 21.0	37.7 ± 71.9

Study locations

16 sites

Nagoya City University Hospital ( Site 3328)
Nagoya, Aichi 467-8602, Japan
Idaimae Minamiyojo Int Clinic ( Site 3321)
Sapporo, Hokkaido 064-0804, Japan
Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)
Kakogawa, Hyogo 675-0101, Japan
Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)
Hitachinaka, Ibaraki 312-0057, Japan
Saiseikai Kanazawa Hospital ( Site 3337)
Kanazawa, Ishikawa 920-0353, Japan
Komatsu Municipal Hospital ( Site 3308)
Komatsu, Ishikawa 923-8560, Japan
Kamei Internal Medicine and Respiratory Clinic ( Site 3309)
Takamatsu, Kagawa 761-8073, Japan
Yokohama City Minato Red Cross Hospital ( Site 3306)
Yokohama, Kanagawa 231-8682, Japan
Matsusaka City Hospital ( Site 3325)
Matsusaka, Mie 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

References and documents

Study documents

Protocol and statistical analysis plan · Dec 21, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Registry details

Key details

Study ID: NCT03482713
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Mar 29, 2018
Start date: Mar 16, 2018
Primary completion: Jun 7, 2018
Completion: Jun 7, 2018
Results posted: Jul 5, 2019
Last update: Oct 17, 2019

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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