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

NCT ID: NCT04525885

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-17
• Study Completion Date: 2022-09-15

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.

Detailed Description

This study will have a main 24-week treatment period and a 28-week extension period of treatment. Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period.

Conditions

Chronic Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gefapixant 45 mg BID

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

Group Type: EXPERIMENTAL

Gefapixant 45 mg twice daily (BID)

Intervention Type: DRUG

Gefapixant 45 mg tablet to be administered orally BID

Gefapixant 45 mg BID

Intervention Type: DRUG

Gefapixant 45 mg tablet to be administered orally BID

Gefapixant 15 mg BID

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

Group Type: EXPERIMENTAL

Gefapixant 15 mg BID

Intervention Type: DRUG

Gefapixant 15 mg tablet to be administered orally BID

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet administered orally BID

Interventions

Gefapixant 45 mg twice daily (BID)

Gefapixant 45 mg tablet to be administered orally BID

Intervention Type: DRUG

Gefapixant 15 mg BID

Gefapixant 15 mg tablet to be administered orally BID

Intervention Type: DRUG

Placebo

Placebo tablet administered orally BID

Intervention Type: DRUG

Gefapixant 45 mg BID

Gefapixant 45 mg tablet to be administered orally BID

Intervention Type: DRUG

Other Intervention Names

MK-7264; MK-7264; MK-7264

Eligibility 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 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Fuzhou, Fujian, China

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

Guangzhou, Guangdong, China

Inner Mongolia Autonomous Region Hospital ( Site 5018)

Hohhot, Inner Mongolia, China

The First Affiliated Hospital of Nanchang University ( Site 5012)

Nanchang, Jiangxi, China

ShengJing Hospital of China Medical University ( Site 5024)

Shenyang, Liaoning, China

Shanghai General Hospital ( Site 5010)

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Zhejiang University ( Site 5014)

Hangzhou, Zhejiang, China

Peking University Third Hospital ( Site 5005)

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-7264-030

Identifier Type: OTHER

Identifier Source: secondary_id

MK-7264-030-02

Identifier Type: OTHER

Identifier Source: secondary_id

7264-030 China Extension

Identifier Type: -

Identifier Source: org_study_id