A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)

NCT01432730 | Completed Phase 2 Results

• 4 other identifiers: 7264-006AF219-006MK-7264-0062010-024283-18
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomised, double-blind, placebo-controlled, crossover, single centre study of gefapixant (AF-219/MK-7264) in participants with idiopathic or treatment resistant chronic cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective cough frequency.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Daytime Objective Cough Frequency

  Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake. 24-hour sound recordings were collected using a digital recording device. Change from baseline in awake cough frequency = (post-treatment awake cough frequency - baseline awake cough frequency). A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.

  Baseline (Day 0) and Day 14 of each study period

Secondary Outcomes (8)

• Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)

  Baseline (Day 0) and Day 15 of each study period

• Change From Baseline in Nighttime Objective Cough Frequency

  Baseline (Day 0) and Day 14 of each study period

• Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)

  Baseline (Day 0) and Day 15 of each study period

• Change From Baseline of 24-hour Objective Cough Frequency

  24 hours at Baseline (Day 0) and Day 14 of each study period

• Global Rating of Change Score for Cough Frequency

  Day 15 of each study period

Other Outcomes (7)

• Baseline Daytime Cough Frequency

  Baseline (Day 0) of each study period

• Baseline Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)

  Baseline (Day 0) of each study period

• Baseline Nighttime Objective Cough Frequency

  Baseline (Day 0) of each study period

Study Arms (2)

Gefapixant 600 mg>Placebo

EXPERIMENTAL

Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks.

Drug: Gefapixant; Drug: Placebo

Placebo>Gefapixant 600 mg

EXPERIMENTAL

Placebo to gefapixant BID, taken orally for 2 weeks followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks.

Drug: Gefapixant; Drug: Placebo

Interventions

Gefapixant DRUG

Oral tablets, BID

Also known as: AF-219, MK-7264

Gefapixant 600 mg>Placebo; Placebo>Gefapixant 600 mg

Placebo DRUG

Oral tablets, BID

Gefapixant 600 mg>Placebo; Placebo>Gefapixant 600 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[treatment-resistant\]).

You may not qualify if:

• Current smoker
• Individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history
• Treatment with an angiotensin-converting-enzyme inhibitor (ACE-inhibitor) as the potential cause of a participant's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
• Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) \<60%

Sponsors & Collaborators

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

Related Publications (1)

• Abdulqawi R, Dockry R, Holt K, Layton G, McCarthy BG, Ford AP, Smith JA. P2X3 receptor antagonist (AF-219) in refractory chronic cough: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2015 Mar 28;385(9974):1198-205. doi: 10.1016/S0140-6736(14)61255-1. Epub 2014 Nov 25.

  PMID: 25467586 DERIVED

MeSH Terms

Conditions

Chronic Cough

Interventions

Gefapixant

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: September 22, 2011
• Primary Completion: February 7, 2013
• Study Completion: February 21, 2013
• Last Updated: November 24, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share