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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Cough
• Intervention / Treatment: Drug: Gefapixant 45 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 weeks
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.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and Week 4
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.	Baseline and Week 4

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): June 7, 2018
• Study Completion (Actual): June 7, 2018

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 7264-033; MK-7264-033 (Other Identifier: Merck Protocol Number); 183925 (Registry Identifier: JAPIC-CTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• 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