An 8-Week Refractory Chronic Cough Study (MK-7264-021)
A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough
3 other identifiers
interventional
24
1 country
10
Brief Summary
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2015
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2015
CompletedFirst Posted
Study publicly available on registry
November 24, 2015
CompletedStudy Start
First participant enrolled
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2016
CompletedResults Posted
Study results publicly available
November 25, 2019
CompletedNovember 25, 2019
November 1, 2019
5 months
November 20, 2015
October 23, 2019
November 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Week 8 (Day 56)
Study Arms (4)
Gefapixant 15 mg twice daily
EXPERIMENTALTwo 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Gefapixant 30 mg twice daily
EXPERIMENTALFour 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Gefapixant 50 mg twice daily
EXPERIMENTALOne 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
Placebo to match gefapixant
EXPERIMENTALMatching placebo tablets administered by mouth twice daily for 8 weeks
Interventions
Gefapixant tablets administered by mouth twice daily for 8 weeks
Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Afferent Investigative Site
Mission Viejo, California, United States
Afferent Investigative Site
San Jose, California, United States
Afferent Investigative Site
Colorado Springs, Colorado, United States
Afferent Investigative Site
Largo, Florida, United States
Afferent Investigative Site
Charlotte, North Carolina, United States
Afferent Investigative Site
Tulsa, Oklahoma, United States
Afferent Investigative Site
Dallas, Texas, United States
Afferent Investigative Site
San Antonio, Texas, United States
Afferent Investigative Site
Bellevue, Washington, United States
Afferent Investigative Site
Greenfield, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2015
First Posted
November 24, 2015
Study Start
December 17, 2015
Primary Completion
May 4, 2016
Study Completion
May 18, 2016
Last Updated
November 25, 2019
Results First Posted
November 25, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf