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

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Gefapixant 45 mg
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cough

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study

Sites / Locations

  • Nagoya City University Hospital ( Site 3328)
  • Idaimae Minamiyojo Int Clinic ( Site 3321)
  • Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)
  • Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)
  • Saiseikai Kanazawa Hospital ( Site 3337)
  • Komatsu Municipal Hospital ( Site 3308)
  • Kamei Internal Medicine and Respiratory Clinic ( Site 3309)
  • Yokohama City Minato Red Cross Hospital ( Site 3306)
  • Matsusaka City Hospital ( Site 3325)
  • Nagaoka Red Cross Hospital ( Site 3307)
  • Kawaguchi Respiratory Clinic ( Site 3304)
  • Fukushima Medical University Hospital ( Site 3338)
  • Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)
  • Nihonbashi Medical & Allergy Clinic ( Site 3334)
  • Fukuwa Clinic ( Site 3311)
  • Showa University Hospital ( Site 3331)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gefapixant 45 mg

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
March 16, 2018
Last Updated
October 16, 2019
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03482713
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
June 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefapixant 45 mg
Arm Type
Experimental
Arm Description
Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a film-coated placebo tablet matching gefapixant BID for 28 days.
Intervention Type
Drug
Intervention Name(s)
Gefapixant 45 mg
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant 45 mg (film-coated tablet) to be administered orally BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (film-coated tablet) matching gefapixant to be administered orally BID
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced an Adverse Event
Description
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
Title
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
Description
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 Outcome Measure Information:
Title
Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour
Description
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
Title
Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital ( Site 3328)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Idaimae Minamiyojo Int Clinic ( Site 3321)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)
City
Kakogawa
State/Province
Hyogo
ZIP/Postal Code
675-0101
Country
Japan
Facility Name
Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)
City
Hitachinaka
State/Province
Ibaraki
ZIP/Postal Code
312-0057
Country
Japan
Facility Name
Saiseikai Kanazawa Hospital ( Site 3337)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-0353
Country
Japan
Facility Name
Komatsu Municipal Hospital ( Site 3308)
City
Komatsu
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Facility Name
Kamei Internal Medicine and Respiratory Clinic ( Site 3309)
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
761-8073
Country
Japan
Facility Name
Yokohama City Minato Red Cross Hospital ( Site 3306)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Matsusaka City Hospital ( Site 3325)
City
Matsusaka
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Nagaoka Red Cross Hospital ( Site 3307)
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Kawaguchi Respiratory Clinic ( Site 3304)
City
Higashiosaka
State/Province
Osaka
ZIP/Postal Code
577-0843
Country
Japan
Facility Name
Fukushima Medical University Hospital ( Site 3338)
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)
City
Tokyo
ZIP/Postal Code
101-0041
Country
Japan
Facility Name
Nihonbashi Medical & Allergy Clinic ( Site 3334)
City
Tokyo
ZIP/Postal Code
103-0022
Country
Japan
Facility Name
Fukuwa Clinic ( Site 3311)
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Showa University Hospital ( Site 3331)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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