Evaluation of S-600918 in Adults With Refractory Chronic Cough
NCT ID: NCT04110054
Last Updated: 2024-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
406 participants
INTERVENTIONAL
2020-02-13
2020-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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S-600918 50 mg
Participants will receive 50 mg S-600918 orally once a day for 28 days.
S-600918
Tablets for oral administration
S-600918 150 mg
Participants will receive 150 mg S-600918 orally once a day for 28 days.
S-600918
Tablets for oral administration
S-600918 300 mg
Participants will receive 300 mg S-600918 orally once a day for 28 days.
S-600918
Tablets for oral administration
Placebo
Participants will receive placebo to S-600918 orally once a day for 28 days.
Placebo to S-600918
Tablets for oral administration
Interventions
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S-600918
Tablets for oral administration
Placebo to S-600918
Tablets for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
* Capable of giving signed informed consent.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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Research Solutions of Arizona
Litchfield Park, Arizona, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
Alliance for Multispecialty Research
Tempe, Arizona, United States
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Institute of HealthCare Assessment, Inc.
San Diego, California, United States
Sher Allergy Specialist/Center for Cough
Largo, Florida, United States
Medical Research Of Central Florida, LLC
Leesburg, Florida, United States
Lenus Research & Medical Group, LLC
Sweetwater, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
University of Kansas Medical Center-Hospital
Kansas City, Kansas, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Abraham Research PLLC
Fort Mitchell, Kentucky, United States
Shionogi Research Site
Bangor, Maine, United States
St. Joseph's Hospital
Bangor, Maine, United States
Minnesota Lung Center
Edina, Minnesota, United States
Mayo Clinic Pulmonary Clinical Research Unit
Rochester, Minnesota, United States
Mayo Clinic, Division of Pulmonary and Critical Care Medicine
Rochester, Minnesota, United States
Minnesota Lung Center
Woodbury, Minnesota, United States
University of Missouri Hospital and Clinics, ENT & Allergy Center of Missouri
Columbia, Missouri, United States
University of Missouri Hospital and Clinics, Hearing and Balance Center
Columbia, Missouri, United States
University of Missouri Hospital - Clinical Research Center
Columbia, Missouri, United States
Clayton Sleep Institute, LLC
St Louis, Missouri, United States
Associated Specialists in Medicine, PC
St Louis, Missouri, United States
The Clinical Research Center, LLC
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Creighton University Clinical Research Office
Omaha, Nebraska, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
American Health Research Inc
Charlotte, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Northwest Research Center
Portland, Oregon, United States
Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island, United States
ADAC Research, PA
Greenville, South Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Pharmaceutical Research & Consulting, Inc
Dallas, Texas, United States
MCA Research
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Allergy and Asthma Care of Waco
Waco, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
Intermountain Clinical Research
Draper, Utah, United States
Tidewater Physicians Multispecialty Group Clinical Research
Williamsburg, Virginia, United States
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States
Fakultní Nemocnice Olomouc
Olomouc, Czech Republic, Czechia
MUDr. I. Čierná-Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav, , Czechia
Plicní Ambulance Rokycany s.r.o.
Rokycany, , Czechia
MUDr. Jaroslav Mareš -
Strakonice, , Czechia
Plicní středisko Teplice s.r.o.
Teplice, , Czechia
Pneumologie Varnsdorf s.r.o.
Varnsdorf, , Czechia
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Fukui Prefectural Hospital
Fukui-shi, Fukui, Japan
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Fukuoka, Japan
Nishi Fukuoka Hospital
Fukuoka, Fukuoka, Japan
Iizuka Hospital
Iizuka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Tohno Chuo Clinic
Mizunami-shi, Gifu, Japan
Mazda Hospital of Mazda Motor Corporation
Aki-gun, Hiroshima, Japan
Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
Fukuyama, Hiroshima, Japan
Makita Hospital
Sapporo, Hokkaido, Japan
Idaimae Minamiyojo Int Clinic
Sapporo, Hokkaido, Japan
Nakatani Hospital
Himeji, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Hitachi, Ltd. Hitachinaka General Hospital
Hitachi-Naka, Ibaraki, Japan
National Hospital Organization Ibarakihigashi National Hospital
Naka-gun, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Sakaide City Hospital
Sakaide-shi, Kagawa-ken, Japan
Kamei Internal Medicine and Respiratory Clinic
Takamatsu, Kagawa-ken, Japan
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara-shi, Kanagawa, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
Yokohama, Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Tohoku Rosai Hospital
Sendai, Miyagi, Japan
Lee's Clinic
Osaka, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi, Osaka, Japan
Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
Hamamatsu, Shizuoka, Japan
Shizuoka General Hospital
Shizuoka, Shizuoka, Japan
Nihonbashi Medical & Allergy Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Takahashi Medical Clinic
Kokubunji-shi, Tokyo, Japan
Senzoku Kokyuuki Allergy Clinic
Ōta-ku, Tokyo, Japan
Yoga Allergy Clinic
Setagaya City, Tokyo, Japan
KONO Medical Clinic
Setagaya-ku, Tokyo, Japan
Koukokukai Ebisu Clinic
Shibuya-shi, Tokyo, Japan
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
Shinagawa-ku, Tokyo, Japan
Kouwakai Kouwa Clinic
Toshima-ku, Tokyo, Japan
Shimonoseki City Hospital
Shimonoseki-shi, Yamaguchi, Japan
Prywatny Gabinet lnternistyczno-Alergologiczny
Bialystok, , Poland
Centrum Medycyny Oddechowej Mroz sp. j.
Bialystok, , Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, , Poland
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Centrum Medyczne Silmedic Sp. z o. o.
Katowice, , Poland
Gyncentrum Sp. Z o. o.
Katowice, , Poland
Diamond Clinic
Krakow, , Poland
Poradnia Alergologiczna SPZOZ USK nr 1 UM w Lodzi
Lodz, , Poland
Ostrowieckie CM S.C. A. Olech-Cudzik, K. Cudzik
Ostrowiec Świętokrzyski, , Poland
Centrum Alergologii Teresa Hofman Sp. Z o.o.
Poznan, , Poland
RCMed Oddz. Sochaczew
Sochaczew, , Poland
Centrum Medyczne Lucyna Andrzej Dymek
Strzelce Opolskie, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska
Tarnów, , Poland
Chernihiv City Hospital #2, Therapy Department
Chernihiv, , Ukraine
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
Kharkiv, , Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Pulmonary-Allergological Department with Immunological and Therapeutic Beds
Kharkiv, , Ukraine
City Clinical Hospital #13
Kharkiv, , Ukraine
Communal Non-profit Enterprise "Kherson City Clinical Hospital named after Ye. Ye. Karabelesh" of the Kherson City Council, Pulmonary Therapeutic Department
Kherson, , Ukraine
Medical Center of LLC Medical Clinic Blagomed
Kyiv, , Ukraine
Medical Center of Edelweiss Medics LLC , Treatment and Prevention Department
Kyiv, , Ukraine
Municipal Non-commercial Enterprise "Consultative-Diagnostics Center" of Desnyanskyi District of Kyiv, Therapy Department
Kyiv, , Ukraine
Medical Center of LLC Medbud-Clinic, Treatment and Prevention Department
Kyiv, , Ukraine
National Institute of Phthisiology and Pulmonology, Department of Pulmonology
Kyiv, , Ukraine
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
Kyiv, , Ukraine
Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Department of Pulmonology
Kyiv, , Ukraine
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
Kyiv, , Ukraine
Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Pulmonology Department
Lutsk, , Ukraine
The 1st City Clinical Hospital of Poltava City Council
Poltava, , Ukraine
Small Business Private Enterprise Medical Centre "Pulse", Therapeutic Department
Vinnytsia, , Ukraine
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
Vinnytsia, , Ukraine
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Medinova Research Northamptonshire Quality Research Site
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Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
North Shields, Northumberland, United Kingdom
Medinova Yorkshire Quality Research Site
Bradford, West Yorkshire, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Kings College Hospital
London, , United Kingdom
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Yate, , United Kingdom
Countries
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References
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McGarvey L, Smith JA, Morice A, Birring SS, Chung KF, Dicpinigaitis PV, Niimi A, Benninger MS, Sher M, Matsunaga Y, Miyazaki S, Machida M, Ishihara H, Mahmood A, Gomez JC. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2b Trial of P2X3 Receptor Antagonist Sivopixant for Refractory or Unexplained Chronic Cough. Lung. 2023 Feb;201(1):25-35. doi: 10.1007/s00408-022-00592-5. Epub 2022 Dec 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1812VA323
Identifier Type: -
Identifier Source: org_study_id
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