A Phase 2, randomized, double-blind, cross-over study of S-600918 in subjects with refractory/unexplained chronic cough
Phase 2
Completed
- Conditions
- Refractory/unexplained chronic cough
- Registration Number
- JPRN-jRCT2080223969
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Main inclusion criteria
Subjects with refractory/unexplained chronic cough continuing for 6 months or more
Exclusion Criteria
Main exclusion criteria
Smokers or subjects who started smoking cessation within the last 6 months or former smokers with a pack/year history greater than 20 pack-years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Rate of change in the number of coughs per hour in the daytime from baseline after administration of S-600918 for 2 weeks
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>Plasma concentrations of S-600918 and its metabolite, Adverse events (AEs), Treatment-related AEs, Clinical laboratory tests, Blood pressure and pulse rate, Electrocardiogram (ECG)