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

Acute Cough Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03569033
• Other study ID #: 7264-013
• Secondary ID: MK-7264-0132017-
• Status: Terminated
• Phase: Phase 2
• Start date: July 4, 2018
• Est. completion date: November 19, 2018

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: November 19, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cough
• Cough
• Respiratory Tract Infections

Intervention

Drug:
• Gefapixant
Gefapixant 45 mg will be administered orally.
• Placebo
Placebo tablet matching gefapixant will be administered orally.

Locations

Country	Name	City	State
United Kingdom	Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)	London

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 3
Secondary	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.	Baseline and Day 3
Secondary	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.	Baseline and Day 3
Secondary	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.	Baseline and Day 3
Secondary	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.	Up to 21 days
Secondary	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.	Up to Day 7