A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension

NCT04525885 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 7264-030 China ExtensionMK-7264-030MK-7264-030-02
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 8

Brief Summary

The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (3)

• Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24

  24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.

  Baseline, Week 24

• Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up

  Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.

  Up to 54 weeks

• Percentage of Participants Who Discontinued Treatment Due to an AE

  Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).

  Up 52 weeks

Secondary Outcomes (6)

• Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline

  Baseline, Week 24

• Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24

  Baseline, Week 24

• Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24

  Baseline, Week 24

• Percentage of Participants With ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24

  Baseline, Week 24

• Percentage of Participants With ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24

  Baseline, Week 24

Study Arms (3)

Gefapixant 45 mg BID

EXPERIMENTAL

Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).

Drug: Gefapixant 45 mg twice daily (BID); Drug: Gefapixant 45 mg BID

Gefapixant 15 mg BID

EXPERIMENTAL

Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).

Drug: Gefapixant 15 mg BID

Placebo

PLACEBO COMPARATOR

Participants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period.

Drug: Placebo

Interventions

Gefapixant 45 mg twice daily (BID) DRUG

Gefapixant 45 mg tablet to be administered orally BID

Also known as: MK-7264

Gefapixant 45 mg BID

Gefapixant 15 mg BID DRUG

Gefapixant 15 mg tablet to be administered orally BID

Also known as: MK-7264

Gefapixant 15 mg BID

Placebo DRUG

Placebo tablet administered orally BID

Placebo

Gefapixant 45 mg BID DRUG

Gefapixant 45 mg tablet to be administered orally BID

Also known as: MK-7264

Gefapixant 45 mg BID

Eligibility Criteria

• Age: 18 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 at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
• 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 greater than 20 pack-years
• Has a history of 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 an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 at Screening OR an eGFR ≥30 mL/min/1.73 m\^2 and \<50 mL/min/1.73 m\^2 at Screening with unstable renal function
• Has a history of malignancy \<=5 years
• Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
• Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
• 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 (8)

The First Affiliated Hospital of Fujian Medical University ( Site 5017)

Fuzhou, Fujian, 350005, China

Location

The First Affiliated Hospital of Guangzhou Medical University ( Site 5000)

Guangzhou, Guangdong, 510120, China

Location

Inner Mongolia Autonomous Region Hospital ( Site 5018)

Hohhot, Inner Mongolia, 010017, China

Location

The First Affiliated Hospital of Nanchang University ( Site 5012)

Nanchang, Jiangxi, 330006, China

Location

ShengJing Hospital of China Medical University ( Site 5024)

Shenyang, Liaoning, 110004, China

Location

Shanghai General Hospital ( Site 5010)

Shanghai, Shanghai Municipality, 200080, China

Location

The First Affiliated Hospital of Zhejiang University ( Site 5014)

Hangzhou, Zhejiang, 310003, China

Location

Peking University Third Hospital ( Site 5005)

Beijing, 100191, China

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Chronic Cough

Interventions

Gefapixant; BID protein, human

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 LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants with refractory or unexplained chronic cough will be randomized to 1 of 3 treatment groups: gefapixant 45 mg twice daily (BID), gefapixant 15 mg BID, or placebo.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 25, 2020
• Study Start: May 17, 2019
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: January 12, 2024
• Results First Posted: October 2, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (8)