A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2016-11-04

Brief Summary

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This study is designed to evaluate the efficacy of three dose regimens of gefapixant (\[MK-7264\] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough frequency. The primary hypothesis for this trial is that at least one dose regimen of gefapixant is superior to placebo with respect to the mean change from baseline in awake cough frequency (on the log scale).

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Detailed Description

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Conditions

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Refractory Chronic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (for gefapixant)

Intervention Type DRUG

Gefapixant 7.5 mg

Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.

Group Type EXPERIMENTAL

Gefapixant

Intervention Type DRUG

Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.

Gefapixant 20 mg

Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.

Group Type EXPERIMENTAL

Gefapixant

Intervention Type DRUG

Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.

Gefapixant 50 mg

Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.

Group Type EXPERIMENTAL

Gefapixant

Intervention Type DRUG

Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.

Interventions

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Gefapixant

Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.

Intervention Type DRUG

Placebo (for gefapixant)

Intervention Type DRUG

Other Intervention Names

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AF-219 MK-7264 Dose-matched placebo tablet to gefapixant administered twice daily.

Eligibility Criteria

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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 in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio \<60%
* History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
* History of opioid use within 1 week of the Baseline Visit
* Body mass index (BMI) \<18 kg/m\^2 or ≥ 40 kg/m\^2
* History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with \<3 excised basal cell carcinomas)
* Screening systolic blood pressure (SBP) \>160 mm Hg or a diastolic blood pressure (DBP) \>90 mm Hg
* Clinically significant abnormal electrocardiogram (ECG) at Screening
* Significantly abnormal laboratory tests at Screening
* 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 participant inappropriate for entry into this trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No