Evaluation of S-600918 in Adults With Refractory Chronic Cough

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-selection Study of S-600918 in Patients With Refractory Chronic Cough

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.

Study Overview

• Status: Completed
• Conditions: Chronic Cough
• Intervention / Treatment: Drug: S-600918; Drug: Placebo to S-600918

• Study Type: Interventional
• Enrollment (Actual): 406
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Brandýs nad Labem-Stará Boleslav, Czechia, 250 01
    • MUDr. I. Čierná-Peterová s.r.o.
  • Rokycany, Czechia, 337 22
    • Plicní Ambulance Rokycany s.r.o.
  • Strakonice, Czechia, 386 01
    • MUDr. Jaroslav Mareš -
  • Teplice, Czechia, 415 01
    • Plicni stredisko Teplice s.r.o.
  • Varnsdorf, Czechia, 407 47
    • Pneumologie Varnsdorf s.r.o.
  • Czech Republic
    • Olomouc, Czech Republic, Czechia, 779 00
      • Fakultni nemocnice Olomouc
• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
  • Fukui
    • Fukui-shi, Fukui, Japan, 910-8526
      • Fukui Prefectural Hospital
  • Fukuoka
    • Fukuoka City, Fukuoka, Japan, 815-8588
      • Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
    • Fukuoka-shi, Fukuoka, Japan, 819-8555
      • Nishi Fukuoka Hospital
    • Iizuka, Fukuoka, Japan, 820-8505
      • Iizuka Hospital
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital
  • Gifu
    • Mizunami-shi, Gifu, Japan, 509-6134
      • Tohno Chuo Clinic
  • Hiroshima
    • Aki-gun, Hiroshima, Japan, 735-8585
      • Mazda Hospital of Mazda Motor Corporation
    • Fukuyama, Hiroshima, Japan, 7200001
      • Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0804
      • Idaimae Minamiyojo Int Clinic
    • Sapporo-city, Hokkaido, Japan, 001-0901
      • Makita Hospital
  • Hyogo
    • Himeji, Hyogo, Japan, 672-8064
      • Nakatani Hospital
    • Kobe City, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Ibaraki
    • Hitachinaka-shi, Ibaraki, Japan, 312-0057
      • Hitachi, Ltd. Hitachinaka General Hospital
    • Naka-gun, Ibaraki, Japan, 319-1113
      • National Hospital Organization Ibarakihigashi National Hospital
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 9208530
      • Ishikawa Prefectural Central Hospital
  • Kagawa
    • Sakaide-shi, Kagawa, Japan, 762-8550
      • Sakaide City Hospital
    • Takamatsu, Kagawa, Japan, 761-8073
      • Kamei Internal medicine and Respiratory Clinic
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-8550
      • Fujisawa City Hospital
    • Sagamihara-shi, Kanagawa, Japan, 252-0392
      • National Hospital Organization Sagamihara National Hospital
    • Yokohama-shi, Kanagawa, Japan, 231-8682
      • Yokohama City Minato Red Cross Hospital
    • Yokohama-shi, Kanagawa, Japan, 223-0059
      • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 606-8507
      • Kyoto University Hospital
  • Miyagi
    • Sendai-City, Miyagi, Japan, 981-8563
      • Tohoku Rosai Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 531-0073
      • Lee's Clinic
    • Sakai-shi, Osaka, Japan, 591-8555
      • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 430-8525
      • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
    • Shizuoka-shi, Shizuoka, Japan, 420-8527
      • Shizuoka General Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0022
      • Nihonbashi Medical & Allergy Clinic
    • Kokubunji-shi, Tokyo, Japan, 185-0014
      • Takahashi Medical Clinic
    • Ota-ku, Tokyo, Japan, 145-0063
      • Senzoku Kokyuuki Allergy Clinic
    • Setagaya, Tokyo, Japan, 158-0097
      • Yoga Allergy Clinic
    • Setagaya-ku, Tokyo, Japan, 157-0072
      • KONO Medical Clinic
    • Shibuya-shi, Tokyo, Japan, 150-0013
      • Koukokukai Ebisu Clinic
    • Shinagawa-ku, Tokyo, Japan, 140-8522
      • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
    • Toshima-ku, Tokyo, Japan, 170-0003
      • Kouwakai Kouwa Clinic
  • Yamaguchi
    • Shimonoseki-shi, Yamaguchi, Japan, 750-8520
      • Shimonoseki City Hospital
• Poland
  • Bialystok, Poland, 15-010
    • Prywatny Gabinet lnternistyczno-Alergologiczny
  • Bialystok, Poland, 15-044
    • Centrum Medycyny Oddechowej Mroz sp. j.
  • Bydgoszcz, Poland, 85-796
    • Centrum Medyczne Pratia Bydgoszcz
  • Gdynia, Poland, 81-338
    • Centrum Medyczne Pratia Gdynia
  • Katowice, Poland, 40-282
    • Centrum Medyczne Silmedic Sp. z o. o.
  • Katowice, Poland, 40-851
    • Gyncentrum Sp. z o. o.
  • Krakow, Poland, 31-559
    • Diamond Clinic
  • Lodz, Poland, 90-141
    • Poradnia Alergologiczna SPZOZ USK nr 1 UM w Lodzi
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Ostrowieckie CM S.C. A. Olech-Cudzik, K. Cudzik
  • Poznan, Poland, 60-214
    • Centrum Alergologii Teresa Hofman Sp. z o.o.
  • Sochaczew, Poland, 96-500
    • RCMed Oddz. Sochaczew
  • Strzelce Opolskie, Poland, 47-100
    • Centrum Medyczne Lucyna Andrzej Dymek
  • Tarnow, Poland, 33-100
    • ALERGO-MED Specjalistyczna Przychodnia Lekarska
• Ukraine
  • Chernihiv, Ukraine, 14034
    • Chernihiv City Hospital #2, Therapy Department
  • Kharkiv, Ukraine, 61007
    • 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, 61058
    • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Pulmonary-Allergological Department with Immunological and Therapeutic Beds
  • Kharkiv, Ukraine, 61124
    • City Clinical Hospital #13
  • Kherson, Ukraine, 73000
    • Communal Non-profit Enterprise "Kherson City Clinical Hospital named after Ye. Ye. Karabelesh" of the Kherson City Council, Pulmonary Therapeutic Department
  • Kyiv, Ukraine, 01023
    • Medical Center of LLC Medical Clinic Blagomed
  • Kyiv, Ukraine, 02002
    • Medical Center of Edelweiss Medics LLC , Treatment and Prevention Department
  • Kyiv, Ukraine, 03037
    • Medical Center of LLC Medbud-Clinic, Treatment and Prevention Department
  • Kyiv, Ukraine, 03038
    • National Institute of Phthisiology and Pulmonology, Department of Pulmonology
  • Kyiv, Ukraine, 03038
    • 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, 03049
    • Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Department of Pulmonology
  • Kyiv, Ukraine, 03115
    • 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, 02232
    • Municipal Non-commercial Enterprise "Consultative-Diagnostics Center" of Desnyanskyi District of Kyiv, Therapy Department
  • Lutsk, Ukraine, 43005
    • Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Pulmonology Department
  • Poltava, Ukraine, 36039
    • The 1st City Clinical Hospital of Poltava City Council
  • Vinnytsia, Ukraine, 21018
    • 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
  • Vinnytsya, Ukraine, 21001
    • Small Business Private Enterprise Medical Centre "Pulse", Therapeutic Department
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Yate, United Kingdom, BS37 4AX
    • West Walk Surgery
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Respiratory Clinical Trials
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9LT
      • Wythenshawe Hospital
  • Kent
    • Sidcup, Kent, United Kingdom, DA14 6LT
      • MeDiNova South London Quality Research Site
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • MeDiNova North London Quality Research Site
    • Northwood, Middlesex, United Kingdom, HA6 2JW
      • BMI Bishops Wood Hospital
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN18 9EZ
      • Medinova Research Northamptonshire Quality Research Site
  • Northumberland
    • North Shields, Northumberland, United Kingdom, NE29 8NH
      • Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, 8D18 3SA
      • Medinova Yorkshire Quality Research Site
• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Research Solutions of Arizona
    • Phoenix, Arizona, United States, 85032
      • Pulmonary Associates, PA
    • Tempe, Arizona, United States, 85283
      • Alliance for Multispecialty Research
  • California
    • Los Angeles, California, United States, 90048
      • Southern California Institute for Respiratory Diseases, Inc.
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California dba Southern California Research
    • Northridge, California, United States, 91324
      • California Medical Research Associates, Inc.
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC
    • San Diego, California, United States, 92120
      • Institute of HealthCare Assessment, Inc.
  • Florida
    • Largo, Florida, United States, 33778
      • Sher Allergy Specialist/Center for Cough
    • Leesburg, Florida, United States, 34748
      • Medical Research of Central Florida, LLC
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group, LLC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates, LLC
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center-Hospital
  • Kentucky
    • Fort Mitchell, Kentucky, United States, 41017
      • Abraham Research PLLC
  • Maine
    • Bangor, Maine, United States, 04401
      • Shionogi Research Site
    • Bangor, Maine, United States, 04401
      • St. Joseph's Hospital
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Lung Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Pulmonary Clinical Research Unit
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Division of Pulmonary and Critical Care Medicine
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Lung Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri Hospital and Clinics, ENT & Allergy Center of Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri Hospital and Clinics, Hearing and Balance Center
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital - Clinical Research Center
    • Saint Louis, Missouri, United States, 63141
      • The Clinical Research Center, LLC
    • Saint Louis, Missouri, United States, 63123
      • Clayton Sleep Institute, LLC
    • Saint Louis, Missouri, United States, 63141
      • Associated Specialists in Medicine, PC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Creighton University Clinical Research Office
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research Inc
    • Gastonia, North Carolina, United States, 28504
      • Clinical Research of Gastonia
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97202
      • Northwest Research Center
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central PA, LLC
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • AAPRI Clinical Research Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • ADAC research, PA
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill
  • Texas
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research & Consulting, Inc
    • Houston, Texas, United States, 77084
      • MCA Research
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary and Sleep Center
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
    • Waco, Texas, United States, 76712
      • Allergy and Asthma Care of Waco
  • Utah
    • Draper, Utah, United States, 84020
      • Intermountain Clinical Research
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • Tidewater Physicians Multispecialty Group Clinical Research
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allergy, Asthma & Sinus Center, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-600918 50 mg; Participants will receive 50 mg S-600918 orally once a day for 28 days.	Drug: S-600918; Tablets for oral administration; Other Names: Sivopixant
Experimental: S-600918 150 mg; Participants will receive 150 mg S-600918 orally once a day for 28 days.	Drug: S-600918; Tablets for oral administration; Other Names: Sivopixant
Experimental: S-600918 300 mg; Participants will receive 300 mg S-600918 orally once a day for 28 days.	Drug: S-600918; Tablets for oral administration; Other Names: Sivopixant
Placebo Comparator: Placebo; Participants will receive placebo to S-600918 orally once a day for 28 days.	Drug: Placebo to S-600918; Tablets for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment	Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour in 24 hours at each visit with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the log-transformed coughs per hour in 24 hours at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.	Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment	The number of coughs per hour for 24 hours was measured using a cough monitor.	Baseline to Week 4
Percent Change in Number of Coughs Per Hour While Awake Following 4 Weeks of Study Treatment	Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour while awake at each visit with treatment, week, and treatment-by-week as fixed effect, participants as random effect, and region and the log-transformed coughs per hour while awake at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.	Baseline to Week 4
Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment	The number of coughs per hour while awake was measured using a cough monitor.	Baseline to Week 4
Percent Change in Number of Coughs Per Hour While Asleep Following 4 Weeks of Study Treatment	Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour while asleep at each visit with treatment, week, and treatment-by-week as fixed effect, participants as random effect, and region and the log-transformed coughs per hour while asleep at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.	Baseline to Week 4
Change From Baseline in Weekly Cough Severity Following 4 Weeks of Study Treatment	Cough severity was assessed by the participant by a visual analog scale with numbers from 0 to 100. Results are presented as change from baseline. Reported change is based on a mixed model for the change in weekly cough severity score after 4 weeks of treatment with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the severity score at baseline as covariates. Higher scores indicated higher cough severity.	Baseline to Week 4
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score	The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the participant responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21. Higher score indicates a better quality of life. Results are presented as change from baseline. Reported change is based on a mixed model for the change in LCQ Total Score after 4 weeks of treatment with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the LCQ Score of corresponding domain at baseline as covariates.	Baseline to Week 4
Number of Responders Defined as Participants With an Increase in LCQ of ≥ 1.3 Points	The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the participant responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 2. A higher score indicates a better quality of life.	Baseline to Week 4
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	The ICIQ-SF is a questionnaire used to evaluate the frequency, severity, and impact of urinary incontinence on the quality of life. The questionnaire includes 3 items with responses measured on Likert scales, and 1 item that is measured via a qualitative response. The 3 nominal responses are summed to give the ICIQ score (this total ICIQ-SF score can range from 0 to 21), where a higher score indicates more severe symptoms. The 1 item remaining that is measured via qualitative response is not given a score; rather, the participant selects 1 description out of 8 possible descriptions of this item.	Baseline to Week 4
Change From Baseline in Short Form (36) Health Survey (SF-36)	The SF-36 is a 36-item questionnaire to assesses a participant's health status using 8 health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The mental component reports the average of all the emotionally relevant items and the physical component reports the average of all the physically relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 indicates no disability. Median change can range from -100 to 100. A positive median change indicates an improved outcome.	Baseline to Week 4
Number of Responders as Assessed by Patient Global Impression of Change (PGIC)	The PGIC is a patient-reported measure of overall health status and consists of 1 item adapted from the Clinical Global Impressions scale. The participant selects 1 description out of 7 possible descriptions of this item. The descriptions are numbered from 1 through 7, where lower numbers indicate better quality of life. Participants were considered responders if they reported "Very much improved", "Much improved", or "Minimally improved" from baseline on the PGIC assessment.	Week 4

Collaborators and Investigators

• Sponsor: Shionogi
• Investigators: Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line, Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): December 8, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: P2X3 receptor antagonist; Refractory chronic cough; S-600918
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Chronic Cough
• Other Study ID Numbers: 1812VA323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No