Clinical trial NCT04110054: Evaluation of S-600918 in Adults With Refractory Chronic Cough
Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-selection Study of S-600918 in Patients With Refractory Chronic Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Cough
Keywords: P2X3 receptor antagonist
Refractory chronic cough
S-600918
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment
timeFrame: Baseline to Week 4
measure: Percent Change in Number of Coughs Per Hour While Awake Following 4 Weeks of Study Treatment
timeFrame: Baseline to Week 4
measure: Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment
timeFrame: Baseline to Week 4
measure: Percent Change in Number of Coughs Per Hour While Asleep Following 4 Weeks of Study Treatment
timeFrame: Baseline to Week 4
measure: Change From Baseline in Weekly Cough Severity Following 4 Weeks of Study Treatment
timeFrame: Baseline to Week 4
measure: Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score
timeFrame: Baseline to Week 4
measure: Number of Responders Defined as Participants With an Increase in LCQ of ≥ 1.3 Points
timeFrame: Baseline to Week 4
measure: Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: Baseline to Week 4
measure: Change From Baseline in Short Form (36) Health Survey (SF-36)
timeFrame: Baseline to Week 4
measure: Number of Responders as Assessed by Patient Global Impression of Change (PGIC)
timeFrame: Week 4
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research
state: Arizona
city: Los Angeles
country: United States
facility: Southern California Institute For Respiratory Diseases, Inc.
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California dba Southern California Research
state: California
city: Northridge
country: United States
facility: California Medical Research Associates, Inc.
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: Institute of HealthCare Assessment, Inc.
state: California
city: Largo
country: United States
facility: Sher Allergy Specialist/Center for Cough
state: Florida
city: Leesburg
country: United States
facility: Medical Research Of Central Florida, LLC
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group, LLC
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center-Hospital
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Fort Mitchell
country: United States
facility: Abraham Research PLLC
state: Kentucky
city: Bangor
country: United States
facility: Shionogi Research Site
state: Maine
city: Bangor
country: United States
facility: St. Joseph's Hospital
state: Maine
city: Edina
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Pulmonary Clinical Research Unit
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, Division of Pulmonary and Critical Care Medicine
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Hospital and Clinics, ENT & Allergy Center of Missouri
state: Missouri
city: Columbia
country: United States
facility: University of Missouri Hospital and Clinics, Hearing and Balance Center
state: Missouri
city: Columbia
country: United States
facility: University of Missouri Hospital - Clinical Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Sleep Institute, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Associated Specialists in Medicine, PC
state: Missouri
city: Saint Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Omaha
country: United States
facility: Creighton University Clinical Research Office
state: Nebraska
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA, LLC
state: Pennsylvania
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Greenville
country: United States
facility: ADAC Research, PA
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting, Inc
state: Texas
city: Houston
country: United States
facility: MCA Research
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Waco
country: United States
facility: Allergy and Asthma Care of Waco
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Draper
country: United States
facility: Intermountain Clinical Research
state: Utah
city: Williamsburg
country: United States
facility: Tidewater Physicians Multispecialty Group Clinical Research
state: Virginia
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Center, S.C.
state: Wisconsin
city: Olomouc
country: Czechia
facility: Fakultní Nemocnice Olomouc
state: Czech Republic
city: Brandýs nad Labem-Stará Boleslav
country: Czechia
facility: MUDr. I. Čierná-Peterová s.r.o.
city: Rokycany
country: Czechia
facility: Plicní Ambulance Rokycany s.r.o.
city: Strakonice
country: Czechia
facility: MUDr. Jaroslav Mareš -
city: Teplice
country: Czechia
facility: Plicní středisko Teplice s.r.o.
city: Varnsdorf
country: Czechia
facility: Pneumologie Varnsdorf s.r.o.
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Fukui-shi
country: Japan
facility: Fukui Prefectural Hospital
state: Fukui
city: Fukuoka City
country: Japan
facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Nishi Fukuoka Hospital
state: Fukuoka
city: Iizuka
country: Japan
facility: Iizuka Hospital
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Mizunami-shi
country: Japan
facility: Tohno Chuo Clinic
state: Gifu
city: Aki-gun
country: Japan
facility: Mazda Hospital of Mazda Motor Corporation
state: Hiroshima
city: Fukuyama
country: Japan
facility: Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
state: Hiroshima
city: Sapporo-city
country: Japan
facility: Makita Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Idaimae Minamiyojo Int Clinic
state: Hokkaido
city: Himeji
country: Japan
facility: Nakatani Hospital
state: Hyogo
city: Kobe City
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Hitachinaka-shi
country: Japan
facility: Hitachi, Ltd. Hitachinaka General Hospital
state: Ibaraki
city: Naka-gun
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Sakaide-shi
country: Japan
facility: Sakaide City Hospital
state: Kagawa
city: Takamatsu
country: Japan
facility: Kamei Internal Medicine and Respiratory Clinic
state: Kagawa
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Sendai-City
country: Japan
facility: Tohoku Rosai Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Lee's Clinic
state: Osaka
city: Sakai-shi
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Shizuoka General Hospital
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Nihonbashi Medical & Allergy Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Kokubunji-shi
country: Japan
facility: Takahashi Medical Clinic
state: Tokyo
city: Ota-ku
country: Japan
facility: Senzoku Kokyuuki Allergy Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: KONO Medical Clinic
state: Tokyo
city: Setagaya
country: Japan
facility: Yoga Allergy Clinic
state: Tokyo
city: Shibuya-shi
country: Japan
facility: Koukokukai Ebisu Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
state: Tokyo
city: Toshima-ku
country: Japan
facility: Kouwakai Kouwa Clinic
state: Tokyo
city: Shimonoseki-shi
country: Japan
facility: Shimonoseki City Hospital
state: Yamaguchi
city: Bialystok
country: Poland
facility: Prywatny Gabinet lnternistyczno-Alergologiczny
city: Bialystok
country: Poland
facility: Centrum Medycyny Oddechowej Mroz sp. j.
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Katowice
country: Poland
facility: Centrum Medyczne Silmedic Sp. z o. o.
city: Katowice
country: Poland
facility: Gyncentrum Sp. Z o. o.
city: Krakow
country: Poland
facility: Diamond Clinic
city: Lodz
country: Poland
facility: Poradnia Alergologiczna SPZOZ USK nr 1 UM w Lodzi
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ostrowieckie CM S.C. A. Olech-Cudzik, K. Cudzik
city: Poznan
country: Poland
facility: Centrum Alergologii Teresa Hofman Sp. Z o.o.
city: Sochaczew
country: Poland
facility: RCMed Oddz. Sochaczew
city: Strzelce Opolskie
country: Poland
facility: Centrum Medyczne Lucyna Andrzej Dymek
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska
city: Chernihiv
country: Ukraine
facility: Chernihiv City Hospital #2, Therapy Department
city: Kharkiv
country: Ukraine
facility: Medical and Sanitary Unit of Private Joint Stock Company Kharkiv Tractor Plant, Therapeutic Department, Kharkiv Medical Academy of Postgraduate Education, Chair of General Practice-family Medicine
city: Kharkiv
country: Ukraine
facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Pulmonary-Allergological Department with Immunological and Therapeutic Beds
city: Kharkiv
country: Ukraine
facility: City Clinical Hospital #13
city: Kherson
country: Ukraine
facility: Communal Non-profit Enterprise "Kherson City Clinical Hospital named after Ye. Ye. Karabelesh" of the Kherson City Council, Pulmonary Therapeutic Department
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blagomed
city: Kyiv
country: Ukraine
facility: Medical Center of Edelweiss Medics LLC , Treatment and Prevention Department
city: Kyiv
country: Ukraine
facility: Municipal Non-commercial Enterprise "Consultative-Diagnostics Center" of Desnyanskyi District of Kyiv, Therapy Department
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medbud-Clinic, Treatment and Prevention Department
city: Kyiv
country: Ukraine
facility: National Institute of Phthisiology and Pulmonology, Department of Pulmonology
city: Kyiv
country: Ukraine
facility: SI "National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine," Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Diseases
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Department of Pulmonology
city: Kyiv
country: Ukraine
facility: Clinic of SI National Research Centre of Radiation Medicine of NAMS of Ukraine, Unit of Pulmonology of Department of Therapy of Radiation Consequences of Clinical Radiology Institute
city: Lutsk
country: Ukraine
facility: Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Pulmonology Department
city: Poltava
country: Ukraine
facility: The 1st City Clinical Hospital of Poltava City Council
city: Vinnytsia
country: Ukraine
facility: CNE Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC, Regional Treatment and Diagnostic Pulmonology Center, Chair of Internal Medicine #1, Vinnytsia National Medical University n.a.M.I.Pyrogov
city: Vinnytsya
country: Ukraine
facility: Small Business Private Enterprise Medical Centre "Pulse", Therapeutic Department
city: Cottingham
country: United Kingdom
facility: Respiratory Clinical Trials
state: East Yorkshire
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: Greater Manchester
city: Sidcup
country: United Kingdom
facility: MeDiNova South London Quality Research Site
state: Kent
city: Northwood
country: United Kingdom
facility: BMI Bishops Wood Hospital
state: Middlesex
city: Northwood
country: United Kingdom
facility: MeDiNova North London Quality Research Site
state: Middlesex
city: Corby
country: United Kingdom
facility: Medinova Research Northamptonshire Quality Research Site
state: Northamptonshire
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
state: Northumberland
city: Bradford
country: United Kingdom
facility: Medinova Yorkshire Quality Research Site
state: West Yorkshire
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Yate
country: United Kingdom
facility: West Walk Surgery
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: