A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Chronic Cough

Treatments: Drug: Placebo; Drug: Gefapixant 15 mg BID; Drug: Gefapixant 45 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT03449147

7264-030

2017-003559-49 (EudraCT Number)

MK-7264-030 (Other Identifier)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

Full description

This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 12-week, Off-treatment Durability Study Period. Any assessments conducted in the observational period will be exploratory.

Enrollment: 1,317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
• Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
• Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
• Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Exclusion criteria

• Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
• Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
• Has a history of chronic bronchitis
• Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
• Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR an eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
• Has a history of malignancy ≤5 years
• Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
• Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
• Has a known allergy/sensitivity or contraindication to gefapixant
• Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
• Has previously received gefapixant
• Currently participating in or has participated in an interventional clinical study within 30 days of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,317 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive a matching placebo tablet BID during the 24-week main study period and the 28-week extension period.

Treatment:

Drug: Placebo

Gefapixant 15 mg BID

Experimental group

Description:

Participants will receive a gefapixant 15 mg tablet BID and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and the 28-week extension period.

Treatment:

Drug: Gefapixant 15 mg BID

Drug: Placebo

Gefapixant 45 mg BID

Experimental group

Description:

Participants will receive a gefapixant 45 mg tablet BID and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and during the 28-week extension period.

Treatment:

Drug: Gefapixant 45 mg BID

Drug: Placebo