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

NCT03482713 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 7264-033MK-7264-033183925
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 16

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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour

  Baseline and Week 4

• Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour

  Baseline and Week 4

Study Arms (2)

Gefapixant 45 mg

EXPERIMENTAL

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

Drug: Gefapixant 45 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gefapixant 45 mg DRUG

Gefapixant 45 mg (film-coated tablet) to be administered orally BID

Also known as: MK-7264

Gefapixant 45 mg

Placebo DRUG

Placebo (film-coated tablet) matching gefapixant to be administered orally BID

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (16)

Nagoya City University Hospital ( Site 3328)

Nagoya, Aichi-ken, 467-8602, Japan

Location

Idaimae Minamiyojo Int Clinic ( Site 3321)

Sapporo, Hokkaido, 064-0804, Japan

Location

Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314)

Kakogawa, Hyōgo, 675-0101, Japan

Location

Hitachi, Ltd. Hitachinaka General Hospital ( Site 3301)

Hitachi-Naka, Ibaraki, 312-0057, Japan

Location

Saiseikai Kanazawa Hospital ( Site 3337)

Kanazawa, Ishikawa-ken, 920-0353, Japan

Location

Komatsu Municipal Hospital ( Site 3308)

Komatsu, Ishikawa-ken, 923-8560, Japan

Location

Kamei Internal Medicine and Respiratory Clinic ( Site 3309)

Takamatsu, Kagawa-ken, 761-8073, Japan

Location

Yokohama City Minato Red Cross Hospital ( Site 3306)

Yokohama, Kanagawa, 231-8682, Japan

Location

Matsusaka City Hospital ( Site 3325)

Matsusaka, Mie-ken, 515-8544, Japan

Location

Nagaoka Red Cross Hospital ( Site 3307)

Nagaoka, Niigata, 940-2085, Japan

Location

Kawaguchi Respiratory Clinic ( Site 3304)

Higashiosaka, Osaka, 577-0843, Japan

Location

Fukushima Medical University Hospital ( Site 3338)

Fukushima, 960-1295, Japan

Location

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 3310)

Tokyo, 101-0041, Japan

Location

Nihonbashi Medical & Allergy Clinic ( Site 3334)

Tokyo, 103-0022, Japan

Location

Fukuwa Clinic ( Site 3311)

Tokyo, 103-0027, Japan

Location

Showa University Hospital ( Site 3331)

Tokyo, 142-8666, Japan

Location

MeSH Terms

Conditions

Chronic Cough

Interventions

Gefapixant

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-80-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 29, 2018
• Study Start: March 16, 2018
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: October 17, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (16)