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Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03482713•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (16)

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

Key Dates

Start Date

March 16, 2018

Primary Completion Date

June 7, 2018

Completion Date

June 7, 2018

Last Updated

October 17, 2019

Enrollment

ACTUAL participants

Conditions

Chronic Cough

Interventions

Gefapixant 45 mg

DRUG

Placebo

DRUG

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Chronic Cough

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A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Analysis of the Reliability and Validity of the Chinese Version of CC-QoL

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

ATP Level and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough

Chronic Cough and Small Fiber Neuropathy

Evaluation of S-600918 in Adults With Refractory Chronic Cough