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

NCT ID: NCT03482713

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-16
• Study Completion Date: 2018-06-07

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.

Conditions

Chronic Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gefapixant 45 mg

Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days.

Group Type: EXPERIMENTAL

Gefapixant 45 mg

Intervention Type: DRUG

Gefapixant 45 mg (film-coated tablet) to be administered orally BID

Placebo

Participants will receive a film-coated placebo tablet matching gefapixant BID for 28 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (film-coated tablet) matching gefapixant to be administered orally BID

Interventions

Gefapixant 45 mg

Gefapixant 45 mg (film-coated tablet) to be administered orally BID

Intervention Type: DRUG

Placebo

Placebo (film-coated tablet) matching gefapixant to be administered orally BID

Intervention Type: DRUG

Other Intervention Names

MK-7264

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Nagoya City University Hospital ( Site 3328)

Nagoya, Aichi-ken, Japan

Idaimae Minamiyojo Int Clinic ( Site 3321)

Sapporo, Hokkaido, Japan

Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)

Kakogawa, Hyōgo, Japan

Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)

Hitachi-Naka, Ibaraki, Japan

Saiseikai Kanazawa Hospital ( Site 3337)

Kanazawa, Ishikawa-ken, Japan

Komatsu Municipal Hospital ( Site 3308)

Komatsu, Ishikawa-ken, Japan

Kamei Internal Medicine and Respiratory Clinic ( Site 3309)

Takamatsu, Kagawa-ken, Japan

Yokohama City Minato Red Cross Hospital ( Site 3306)

Yokohama, Kanagawa, Japan

Matsusaka City Hospital ( Site 3325)

Matsusaka, Mie-ken, Japan

Nagaoka Red Cross Hospital ( Site 3307)

Nagaoka, Niigata, Japan

Kawaguchi Respiratory Clinic ( Site 3304)

Higashiosaka, Osaka, Japan

Fukushima Medical University Hospital ( Site 3338)

Fukushima, , Japan

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)

Tokyo, , Japan

Nihonbashi Medical & Allergy Clinic ( Site 3334)

Tokyo, , Japan

Fukuwa Clinic ( Site 3311)

Tokyo, , Japan

Showa University Hospital ( Site 3331)

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-7264-033

Identifier Type: OTHER

Identifier Source: secondary_id

183925

Identifier Type: REGISTRY

Identifier Source: secondary_id

7264-033

Identifier Type: -

Identifier Source: org_study_id