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Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

Primary Purpose

Acute Cough

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Gefapixant
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cough

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In good general health
  • Susceptible to human rhinovirus type 16 (HRV-16)
  • Male or non-pregnant and non-breast feeding female
  • If female of reproductive potential, agrees to use 1 form of acceptable birth control

Exclusion Criteria:

  • Donated blood within 56 days or donated plasma within 7 days prior to dosing
  • History of significant multiple and/or severe allergies
  • Recent history of respiratory tract infection
  • History of cancer
  • Body mass index <18 kg/m^2 or ≥40 kg/m^2
  • History of major surgery or loss of 1 unit of blood
  • History of allergic reaction to sulfonamides
  • Received medications within 14 days prior to randomization
  • Significantly abnormal laboratory tests at Screening
  • Current smoker, smoked within 5 years of Screening, or significant past smoking history
  • History of alcohol or drug abuse

Sites / Locations

  • Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gefapixant 45 mg BID

Placebo BID

Arm Description

Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days.

Participants will receive a matching placebo tablet BID for 7 days.

Outcomes

Primary Outcome Measures

Awake Coughs Per Hour on Day 3
Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.

Secondary Outcome Measures

Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3
The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.
Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3
The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3.
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3
The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3.
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Full Information

First Posted
June 14, 2018
Last Updated
November 25, 2019
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03569033
Brief Title
Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
Official Title
A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
The data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
November 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefapixant 45 mg BID
Arm Type
Experimental
Arm Description
Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days.
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
Participants will receive a matching placebo tablet BID for 7 days.
Intervention Type
Drug
Intervention Name(s)
Gefapixant
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant 45 mg will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet matching gefapixant will be administered orally.
Primary Outcome Measure Information:
Title
Awake Coughs Per Hour on Day 3
Description
Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3
Description
The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.
Time Frame
Baseline and Day 3
Title
Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3
Description
The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3.
Time Frame
Baseline and Day 3
Title
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3
Description
The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3.
Time Frame
Baseline and Day 3
Title
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time Frame
Up to 21 days
Title
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time Frame
Up to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In good general health Susceptible to human rhinovirus type 16 (HRV-16) Male or non-pregnant and non-breast feeding female If female of reproductive potential, agrees to use 1 form of acceptable birth control Exclusion Criteria: Donated blood within 56 days or donated plasma within 7 days prior to dosing History of significant multiple and/or severe allergies Recent history of respiratory tract infection History of cancer Body mass index <18 kg/m^2 or ≥40 kg/m^2 History of major surgery or loss of 1 unit of blood History of allergic reaction to sulfonamides Received medications within 14 days prior to randomization Significantly abnormal laboratory tests at Screening Current smoker, smoked within 5 years of Screening, or significant past smoking history History of alcohol or drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)
City
London
ZIP/Postal Code
E1 2AX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35969360
Citation
Smith JA, Kitt MM, Bell A, Noulin N, Tzontcheva A, Seng MM, Lu S. Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial. Pulm Ther. 2022 Sep;8(3):297-310. doi: 10.1007/s41030-022-00193-w. Epub 2022 Aug 15.
Results Reference
derived

Learn more about this trial

Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

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