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

Completed · Phase 2 · Has a placebo group

Conditions studied: Refractory Chronic Cough

In brief

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

Key facts

Study ID

NCT02612623

Run by

Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

24

Starts

2015-12-17

Expected to finish

2016-05-18

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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