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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01432730
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : February 12, 2020
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. The primary objective of this study was 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 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 : September 22, 2011
Actual Primary Completion Date : February 7, 2013
Actual Study Completion Date : February 21, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Gefapixant 300 mg>Placebo
Gefapixant, 300 mg, twice daily (BID), oral for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, oral for 2 weeks.
Drug: Gefapixant
Oral tablets, BID
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo
Oral tablets, BID

Experimental: Placebo>Gefapixant 300 mg
Placebo to gefapixant BID, oral for 2 weeks followed by a 2-week washout period and then gefapixant, 300 mg, BID, oral for 2 weeks.
Drug: Gefapixant
Oral tablets, BID
Other Names:
  • AF-219
  • MK-7264

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 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 angiotensin-converting-enzyme inhibitor (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
  • Forced Expiratory Volume (FEV1)/Forced Vital Capacity (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


Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
Investigators
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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):
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Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01432730    
Other Study ID Numbers: 7264-006
AF219-006 ( Other Identifier: Afferent Pharmaceuticals )
MK-7264-006 ( Other Identifier: Merck Protocol Number )
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory