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

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

Status and phase: Completed; Phase 2

Conditions: Refractory Chronic Cough

Treatments: Drug: Placebo (for gefapixant); Drug: Gefapixant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612610

7264-012

AF219-012 (Other Identifier)

2015-005064-42 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 253 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (for gefapixant)

Gefapixant 7.5 mg

Experimental group

Description:

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

Treatment:

Drug: Gefapixant

Gefapixant 20 mg

Experimental group

Description:

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

Treatment:

Drug: Gefapixant

Gefapixant 50 mg

Experimental group

Description:

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

Treatment:

Drug: Gefapixant