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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01432730
First received: September 9, 2011
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Chronic Cough Drug: Gefapixant Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Afferent Pharmaceuticals, Inc.:

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

Enrollment: 22
Actual Study Start Date: August 31, 2011
Study Completion Date: February 28, 2013
Primary Completion Date: February 28, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefapixant Drug: Gefapixant
Oral tablets, BID
Other Names:
  • AF-219
  • MK-7264
Placebo Comparator: Placebo Drug: Placebo
Oral tablets, BID

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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%
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 )
Study First Received: September 9, 2011
Last Updated: April 14, 2017

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

ClinicalTrials.gov processed this record on July 28, 2017