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A Study to Assess the Efficacy of Gefapixant (AF-219/MK-7264), a P2X3 Receptor Antagonist, in Subjects With Chronic Cough

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ClinicalTrials.gov Identifier: NCT01432730
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Cough Drug: Gefapixant Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects With Chronic Cough
Actual Study Start Date : August 31, 2011
Actual Primary Completion Date : February 28, 2013
Actual Study Completion Date : February 28, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Gefapixant Drug: Gefapixant
Oral tablets, BID
Other Names:
  • AF-219
  • MK-7264

Placebo Comparator: Placebo Drug: Placebo
Oral tablets, BID




Primary Outcome Measures :
  1. Change from Baseline in daytime objective cough frequency after 2 weeks gefapixant therapy compared with placebo treatment. [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ACE-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
  • FEV1/FVC <60%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432730


Locations
United Kingdom
North West Lung Research Centre, Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jaclyn A Smith, MB, ChB, MRCP, PhD University Hospital of South Manchester

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01432730     History of Changes
Other Study ID Numbers: 7264-006
AF219-006 ( Other Identifier: Afferent Pharmaceuticals )
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms