Clinical trial NCT03482713: Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)
Official title: Phase II Study, Randomized, Double-Blind, Placebo-Controlled 4-Week Clinical Study, to Evaluate the Efficacy and Safety of MK-7264 in Adult Japanese Participants With Unexplained or Refractory Chronic Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Cough
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: Up to 6 weeks
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour
timeFrame: Baseline and Week 4
measure: Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital ( Site 3328)
state: Aichi
city: Sapporo
country: Japan
facility: Idaimae Minamiyojo Int Clinic ( Site 3321)
state: Hokkaido
city: Kakogawa
country: Japan
facility: Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)
state: Hyogo
city: Hitachinaka
country: Japan
facility: Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)
state: Ibaraki
city: Kanazawa
country: Japan
facility: Saiseikai Kanazawa Hospital ( Site 3337)
state: Ishikawa
city: Komatsu
country: Japan
facility: Komatsu Municipal Hospital ( Site 3308)
state: Ishikawa
city: Takamatsu
country: Japan
facility: Kamei Internal Medicine and Respiratory Clinic ( Site 3309)
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital ( Site 3306)
state: Kanagawa
city: Matsusaka
country: Japan
facility: Matsusaka City Hospital ( Site 3325)
state: Mie
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital ( Site 3307)
state: Niigata
city: Higashiosaka
country: Japan
facility: Kawaguchi Respiratory Clinic ( Site 3304)
state: Osaka
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 3338)
city: Tokyo
country: Japan
facility: Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)
city: Tokyo
country: Japan
facility: Nihonbashi Medical & Allergy Clinic ( Site 3334)
city: Tokyo
country: Japan
facility: Fukuwa Clinic ( Site 3311)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 3331)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: