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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)

NCT ID: NCT03569033

Last Updated: 2019-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2018-11-19

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gefapixant 45 mg BID

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

Group Type EXPERIMENTAL

Gefapixant

Intervention Type DRUG

Gefapixant 45 mg will be administered orally.

Placebo BID

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet matching gefapixant will be administered orally.

Interventions

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Gefapixant

Gefapixant 45 mg will be administered orally.

Intervention Type DRUG

Placebo

Placebo tablet matching gefapixant will be administered orally.

Intervention Type DRUG

Other Intervention Names

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MK-7264

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35969360 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MK-7264-013

Identifier Type: OTHER

Identifier Source: secondary_id

2017-000472-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7264-013

Identifier Type: -

Identifier Source: org_study_id