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

Phase 2

Completed

• Conditions: Refractory Chronic Cough
• Interventions: Drug: Gefapixant; Drug: Placebo (for gefapixant)

• Registration Number: NCT02612623
• Lead Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-24
• Study Start: 2015-12-17
• Primary Completion: 2016-05-04
• Study Completion: 2016-05-18
• Results First Submitted: 2019-10-23
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Results First Posted: 2019-11-25
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gefapixant 15 mg twice daily	Gefapixant	Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Placebo to match gefapixant	Placebo (for gefapixant)	Matching placebo tablets administered by mouth twice daily for 8 weeks
Gefapixant 30 mg twice daily	Gefapixant	Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Gefapixant 50 mg twice daily	Gefapixant	One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.	Baseline and Week 8 (Day 56)	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.

Trial Locations

Locations (1)

Afferent Investigative Site; 🇺🇸 Greenfield, Wisconsin, United States