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

Chronic Cough Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482713
• Other study ID #: 7264-033
• Secondary ID: MK-7264-03318392
• Status: Completed
• Phase: Phase 2
• Start date: March 16, 2018
• Est. completion date: June 7, 2018

Study information

• Verified date: October 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Drug:
• Gefapixant 45 mg
Gefapixant 45 mg (film-coated tablet) to be administered orally BID
• Placebo
Placebo (film-coated tablet) matching gefapixant to be administered orally BID

Locations

Country	Name	City	State
Japan	Fukushima Medical University Hospital ( Site 3338)	Fukushima
Japan	Kawaguchi Respiratory Clinic ( Site 3304)	Higashiosaka	Osaka
Japan	Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)	Hitachinaka	Ibaraki
Japan	Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)	Kakogawa	Hyogo
Japan	Saiseikai Kanazawa Hospital ( Site 3337)	Kanazawa	Ishikawa
Japan	Komatsu Municipal Hospital ( Site 3308)	Komatsu	Ishikawa
Japan	Matsusaka City Hospital ( Site 3325)	Matsusaka	Mie
Japan	Nagaoka Red Cross Hospital ( Site 3307)	Nagaoka	Niigata
Japan	Nagoya City University Hospital ( Site 3328)	Nagoya	Aichi
Japan	Idaimae Minamiyojo Int Clinic ( Site 3321)	Sapporo	Hokkaido
Japan	Kamei Internal Medicine and Respiratory Clinic ( Site 3309)	Takamatsu	Kagawa
Japan	Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)	Tokyo
Japan	Fukuwa Clinic ( Site 3311)	Tokyo
Japan	Nihonbashi Medical & Allergy Clinic ( Site 3334)	Tokyo
Japan	Showa University Hospital ( Site 3331)	Tokyo
Japan	Yokohama City Minato Red Cross Hospital ( Site 3306)	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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