Evaluation of S-600918 in Adults With Refractory Chronic Cough

Shionogi

Status and phase: Completed; Phase 2

Conditions: Chronic Cough

Treatments: Drug: S-600918; Drug: Placebo to S-600918

Study type: Interventional

Funder types: Industry

Identifiers

NCT04110054

1812VA323

Details and patient eligibility

About

The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.

Enrollment: 406 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
• If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
• Capable of giving signed informed consent.

Key Exclusion Criteria:

• Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
• Has chronic obstructive pulmonary disease or uncontrolled asthma.
• Has a clinically unstable medical condition.
• History of or ongoing significant psychiatric disorder.
• History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
• History of malignancy in the last 5 years.
• History of severe drug allergy.
• History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
• Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
• Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
• Received S-600918 previously.
• Received an investigational drug in the last 3 months.
• Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
• Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
• If female, pregnant or trying to become pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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406 participants in 4 patient groups, including a placebo group

S-600918 50 mg

Experimental group

Description:

Participants will receive 50 mg S-600918 orally once a day for 28 days.

Treatment:

Drug: S-600918

S-600918 150 mg

Experimental group

Description:

Participants will receive 150 mg S-600918 orally once a day for 28 days.

Treatment:

Drug: S-600918

S-600918 300 mg

Experimental group

Description:

Participants will receive 300 mg S-600918 orally once a day for 28 days.

Treatment:

Drug: S-600918

Placebo

Placebo Comparator group

Description:

Participants will receive placebo to S-600918 orally once a day for 28 days.

Treatment:

Drug: Placebo to S-600918