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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482713
Recruitment Status : Completed
First Posted : March 29, 2018
Results First Posted : July 5, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Chronic Cough Drug: Gefapixant 45 mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Gefapixant 45 mg
Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days.
Drug: Gefapixant 45 mg
Gefapixant 45 mg (film-coated tablet) to be administered orally BID
Other Name: MK-7264

Placebo Comparator: Placebo
Participants will receive a film-coated placebo tablet matching gefapixant BID for 28 days.
Drug: Placebo
Placebo (film-coated tablet) matching gefapixant to be administered orally BID




Primary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to 6 weeks ]
    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.

  2. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event [ Time Frame: Up to 4 weeks ]
    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 :
  1. Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour [ Time Frame: Baseline and Week 4 ]
    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).

  2. Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour [ Time Frame: Baseline and Week 4 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482713


Locations
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Japan
Nagoya City University Hospital ( Site 3328)
Nagoya, Aichi, Japan, 467-8602
Idaimae Minamiyojo Int Clinic ( Site 3321)
Sapporo, Hokkaido, Japan, 064-0804
Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)
Kakogawa, Hyogo, Japan, 675-0101
Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)
Hitachinaka, Ibaraki, Japan, 312-0057
Saiseikai Kanazawa Hospital ( Site 3337)
Kanazawa, Ishikawa, Japan, 920-0353
Komatsu Municipal Hospital ( Site 3308)
Komatsu, Ishikawa, Japan, 923-8560
Kamei Internal Medicine and Respiratory Clinic ( Site 3309)
Takamatsu, Kagawa, Japan, 761-8073
Yokohama City Minato Red Cross Hospital ( Site 3306)
Yokohama, Kanagawa, Japan, 231-8682
Matsusaka City Hospital ( Site 3325)
Matsusaka, Mie, Japan, 515-8544
Nagaoka Red Cross Hospital ( Site 3307)
Nagaoka, Niigata, Japan, 940-2085
Kawaguchi Respiratory Clinic ( Site 3304)
Higashiosaka, Osaka, Japan, 577-0843
Fukushima Medical University Hospital ( Site 3338)
Fukushima, Japan, 960-1295
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)
Tokyo, Japan, 101-0041
Nihonbashi Medical & Allergy Clinic ( Site 3334)
Tokyo, Japan, 103-0022
Fukuwa Clinic ( Site 3311)
Tokyo, Japan, 103-0027
Showa University Hospital ( Site 3331)
Tokyo, Japan, 142-8666
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme Corp.:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03482713    
Other Study ID Numbers: 7264-033
MK-7264-033 ( Other Identifier: Merck Protocol Number )
183925 ( Registry Identifier: JAPIC-CTI )
First Posted: March 29, 2018    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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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
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms