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A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)

NCT ID: NCT01432730

Last Updated: 2020-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-22

Study Completion Date

2013-02-21

Brief Summary

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This is a randomised, double-blind, placebo-controlled, crossover, single centre study of gefapixant (AF-219/MK-7264) in participants with idiopathic or treatment resistant chronic cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective cough frequency.

Detailed Description

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Conditions

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Chronic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gefapixant 600 mg>Placebo

Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks.

Group Type EXPERIMENTAL

Gefapixant

Intervention Type DRUG

Oral tablets, BID

Placebo

Intervention Type DRUG

Oral tablets, BID

Placebo>Gefapixant 600 mg

Placebo to gefapixant BID, taken orally for 2 weeks followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks.

Group Type EXPERIMENTAL

Gefapixant

Intervention Type DRUG

Oral tablets, BID

Placebo

Intervention Type DRUG

Oral tablets, BID

Interventions

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Gefapixant

Oral tablets, BID

Intervention Type DRUG

Placebo

Oral tablets, BID

Intervention Type DRUG

Other Intervention Names

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AF-219 MK-7264

Eligibility Criteria

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Inclusion Criteria

* History of cough for more than 8 weeks
* Normal chest radiograph
* Idiopathic or treatment resistant cough (idiopathic defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip \[treatment-resistant\]).

Exclusion Criteria

* Current smoker
* Individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history
* Treatment with an angiotensin-converting-enzyme inhibitor (ACE-inhibitor) as the potential cause of a participant's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
* Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) \<60%
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Countries

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United Kingdom

References

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Abdulqawi R, Dockry R, Holt K, Layton G, McCarthy BG, Ford AP, Smith JA. P2X3 receptor antagonist (AF-219) in refractory chronic cough: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2015 Mar 28;385(9974):1198-205. doi: 10.1016/S0140-6736(14)61255-1. Epub 2014 Nov 25.

Reference Type DERIVED
PMID: 25467586 (View on PubMed)

Other Identifiers

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AF219-006

Identifier Type: OTHER

Identifier Source: secondary_id

MK-7264-006

Identifier Type: OTHER

Identifier Source: secondary_id

2010-024283-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7264-006

Identifier Type: -

Identifier Source: org_study_id