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An 8-Week Refractory Chronic Cough Study (MK-7264-021)

Primary Purpose

Refractory Chronic Cough

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gefapixant
Placebo (for gefapixant)
Sponsored by
Afferent Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Chronic Cough

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Women and Men between 18 and 80 years of age inclusive
  • Have refractory chronic cough
  • Women of child-bearing potential must use 2 forms of acceptable birth control
  • Have provided written informed consent.
  • Are willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

  • Current smoker
  • Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
  • History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
  • History of opioid use within 1 week of the Baseline Visit
  • Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
  • History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
  • Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
  • Significantly abnormal laboratory tests at Screening
  • Clinically significant abnormal electrocardiogram (ECG)
  • Pregnant or Breastfeeding
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial

Sites / Locations

  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site
  • Afferent Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Gefapixant 15 mg twice daily

Gefapixant 30 mg twice daily

Gefapixant 50 mg twice daily

Placebo to match gefapixant

Arm Description

Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks

Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks

One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks

Matching placebo tablets administered by mouth twice daily for 8 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2015
Last Updated
November 19, 2019
Sponsor
Afferent Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02612623
Brief Title
An 8-Week Refractory Chronic Cough Study (MK-7264-021)
Official Title
A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 17, 2015 (Actual)
Primary Completion Date
May 4, 2016 (Actual)
Study Completion Date
May 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Afferent Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefapixant 15 mg twice daily
Arm Type
Experimental
Arm Description
Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Arm Title
Gefapixant 30 mg twice daily
Arm Type
Experimental
Arm Description
Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Arm Title
Gefapixant 50 mg twice daily
Arm Type
Experimental
Arm Description
One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
Arm Title
Placebo to match gefapixant
Arm Type
Experimental
Arm Description
Matching placebo tablets administered by mouth twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Gefapixant
Other Intervention Name(s)
AF-219, MK-7264
Intervention Description
Gefapixant tablets administered by mouth twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (for gefapixant)
Intervention Description
Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
Description
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.
Time Frame
Baseline and Week 8 (Day 56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women and Men between 18 and 80 years of age inclusive Have refractory chronic cough Women of child-bearing potential must use 2 forms of acceptable birth control Have provided written informed consent. Are willing and able to comply with all aspects of the protocol. Exclusion Criteria: Current smoker Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60% History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline History of opioid use within 1 week of the Baseline Visit Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2 History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas) Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg Significantly abnormal laboratory tests at Screening Clinically significant abnormal electrocardiogram (ECG) Pregnant or Breastfeeding Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Afferent Investigative Site
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Afferent Investigative Site
City
San Jose
State/Province
California
Country
United States
Facility Name
Afferent Investigative Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Afferent Investigative Site
City
Largo
State/Province
Florida
Country
United States
Facility Name
Afferent Investigative Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Afferent Investigative Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Afferent Investigative Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Afferent Investigative Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Afferent Investigative Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Afferent Investigative Site
City
Greenfield
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

An 8-Week Refractory Chronic Cough Study (MK-7264-021)

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