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Evaluation of S-600918 in Adults With Refractory Chronic Cough

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
S-600918
Placebo to S-600918
Sponsored by
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cough focused on measuring P2X3 receptor antagonist, Refractory chronic cough, S-600918

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Solutions of Arizona
  • Pulmonary Associates, PA
  • Alliance for Multispecialty Research
  • Southern California Institute For Respiratory Diseases, Inc.
  • Allergy & Asthma Associates of Southern California dba Southern California Research
  • California Medical Research Associates, Inc.
  • Center for Clinical Trials, LLC
  • Institute of HealthCare Assessment, Inc.
  • Sher Allergy Specialist/Center for Cough
  • Medical Research Of Central Florida, LLC
  • Lenus Research & Medical Group, LLC
  • Rush University Medical Center
  • Sneeze, Wheeze, & Itch Associates, LLC
  • University of Kansas Medical Center-Hospital
  • University of Kansas Medical Center
  • Abraham Research PLLC
  • Shionogi Research Site
  • St. Joseph's Hospital
  • Minnesota Lung Center
  • Mayo Clinic Pulmonary Clinical Research Unit
  • Mayo Clinic, Division of Pulmonary and Critical Care Medicine
  • Minnesota Lung Center
  • University of Missouri Hospital and Clinics, ENT & Allergy Center of Missouri
  • University of Missouri Hospital and Clinics, Hearing and Balance Center
  • University of Missouri Hospital - Clinical Research Center
  • Clayton Sleep Institute, LLC
  • Associated Specialists in Medicine, PC
  • The Clinical Research Center, LLC
  • Montana Medical Research, Inc.
  • Creighton University Clinical Research Office
  • Atlantic Research Center, LLC
  • Montefiore Medical Center
  • American Health Research Inc
  • Clinical Research of Gastonia
  • Southeastern Research Center
  • New Horizons Clinical Research
  • Cleveland Clinic Foundation
  • Northwest Research Center
  • Clinical Research Associaes of Central PA, LLC
  • AAPRI Clinical Research Institute
  • ADAC Research, PA
  • Clinical Research of Rock Hill
  • Pharmaceutical Research & Consulting, Inc
  • MCA Research
  • Metroplex Pulmonary and Sleep Center
  • Diagnostics Research Group
  • Allergy and Asthma Care of Waco
  • Allergy Asthma Research Institute
  • Intermountain Clinical Research
  • Tidewater Physicians Multispecialty Group Clinical Research
  • Allergy, Asthma & Sinus Center, S.C.
  • Fakultní Nemocnice Olomouc
  • MUDr. I. Čierná-Peterová s.r.o.
  • Plicní Ambulance Rokycany s.r.o.
  • MUDr. Jaroslav Mareš -
  • Plicní středisko Teplice s.r.o.
  • Pneumologie Varnsdorf s.r.o.
  • Nagoya City University Hospital
  • Fukui Prefectural Hospital
  • Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
  • Nishi Fukuoka Hospital
  • Iizuka Hospital
  • Fukushima Medical University Hospital
  • Tohno Chuo Clinic
  • Mazda Hospital of Mazda Motor Corporation
  • Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
  • Makita Hospital
  • Idaimae Minamiyojo Int Clinic
  • Nakatani Hospital
  • Kobe University Hospital
  • Hitachi, Ltd. Hitachinaka General Hospital
  • National Hospital Organization Ibarakihigashi National Hospital
  • Ishikawa Prefectural Central Hospital
  • Sakaide City Hospital
  • Kamei Internal Medicine and Respiratory Clinic
  • Fujisawa City Hospital
  • National Hospital Organization Sagamihara National Hospital
  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
  • Yokohama City Minato Red Cross Hospital
  • Kyoto University Hospital
  • Tohoku Rosai Hospital
  • Lee's Clinic
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
  • Shizuoka General Hospital
  • Nihonbashi Medical & Allergy Clinic
  • Fukuwa Clinic
  • Takahashi Medical Clinic
  • Senzoku Kokyuuki Allergy Clinic
  • KONO Medical Clinic
  • Yoga Allergy Clinic
  • Koukokukai Ebisu Clinic
  • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
  • Kouwakai Kouwa Clinic
  • Shimonoseki City Hospital
  • Prywatny Gabinet lnternistyczno-Alergologiczny
  • Centrum Medycyny Oddechowej Mroz sp. j.
  • Centrum Medyczne Pratia Bydgoszcz
  • Centrum Medyczne Pratia Gdynia
  • Centrum Medyczne Silmedic Sp. z o. o.
  • Gyncentrum Sp. Z o. o.
  • Diamond Clinic
  • Poradnia Alergologiczna SPZOZ USK nr 1 UM w Lodzi
  • Ostrowieckie CM S.C. A. Olech-Cudzik, K. Cudzik
  • Centrum Alergologii Teresa Hofman Sp. Z o.o.
  • RCMed Oddz. Sochaczew
  • Centrum Medyczne Lucyna Andrzej Dymek
  • Alergo-Med Specjalistyczna Przychodnia Lekarska
  • Chernihiv City Hospital #2, Therapy Department
  • 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
  • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Pulmonary-Allergological Department with Immunological and Therapeutic Beds
  • City Clinical Hospital #13
  • Communal Non-profit Enterprise "Kherson City Clinical Hospital named after Ye. Ye. Karabelesh" of the Kherson City Council, Pulmonary Therapeutic Department
  • Medical Center of LLC Medical Clinic Blagomed
  • Medical Center of Edelweiss Medics LLC , Treatment and Prevention Department
  • Municipal Non-commercial Enterprise "Consultative-Diagnostics Center"of Desnyanskyi District of Kyiv, Therapy Department
  • Medical Center of LLC Medbud-Clinic, Treatment and Prevention Department
  • National Institute of Phthisiology and Pulmonology, Department of Pulmonology
  • 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 Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Department of Pulmonology
  • 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
  • Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Pulmonology Department
  • The 1st City Clinical Hospital of Poltava City Council
  • 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
  • Small Business Private Enterprise Medical Centre "Pulse", Therapeutic Department
  • Respiratory Clinical Trials
  • Wythenshawe Hospital
  • MeDiNova South London Quality Research Site
  • BMI Bishops Wood Hospital
  • MeDiNova North London Quality Research Site
  • Medinova Research Northamptonshire Quality Research Site
  • Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
  • Medinova Yorkshire Quality Research Site
  • Belfast City Hospital
  • Kings College Hospital
  • West Walk Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

S-600918 50 mg

S-600918 150 mg

S-600918 300 mg

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in Cough at Week 4 Calculated as the Ratio of Number of Coughs per Hour in 24 Hours at Week 4 to Baseline
The number of coughs per hour for 24 hours will be measured using a cough monitor.

Secondary Outcome Measures

Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 30%
The number of coughs per hour for 24 hours will be measured using a cough monitor.
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 50%
The number of coughs per hour for 24 hours will be measured using a cough monitor.
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 70%
The number of coughs per hour for 24 hours will be measured using a cough monitor.
Change in Cough at Week 4 Calculated as the Ratio of the Number of Coughs per Hour While Awake at Week 4 to Baseline
The number of coughs per hour while awake will be measured using a cough monitor.
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 30%
The number of coughs per hour while awake will be measured using a cough monitor.
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 50%
The number of coughs per hour while awake will be measured using a cough monitor.
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 70%
The number of coughs per hour while awake will be measured using a cough monitor.
Change in Cough at Week 4 Calculated as the Ratio of the Number of Coughs per Hour While Asleep at Week 4 to Baseline
The number of coughs per hour while asleep will be measured using a cough monitor.
Change from Baseline in Weekly Cough Severity
Cough severity will be assessed by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Change from Baseline through Day 7 in Daily Cough Severity
Cough severity will be assessed by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Change from Baseline in Leicester Cough Questionnaire (LCQ)
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient 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; a higher score indicates a better quality of life.
Percentage of 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 patient 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; a higher score indicates a better quality of life.
Change from Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
The ICIQ-SF is a patient-reported measure of the severity of urinary incontinence and quality of life (QOL) for those with urinary incontinence. The questionnaire consists of 4 items that evaluate the frequency, severity, and impact of urinary incontinence on QOL. A total score ranging from 0-21 is possible for 3 of the 4 items combined, where a higher score indicates more severe symptoms. The 1 item remaining is not given a score; rather, the patient selects one description out of 8 possible descriptions of this item.
Change from Baseline in Short Form (36) Health Survey (SF-36)
The SF-36 is a patient-reported measure of overall health status. The questionnaire consists of 8 scaled scores (health concepts) and evaluates vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Scores for each scale range from 0 to 100; the lower the score, the greater the disability.
Patient Global Impression of Change (PGIC)
The PGIC is a patient-reported measure of overall health status and consists of one item adapted from the Clinical Global Impressions scale. The patient selects one description out of 7 possible descriptions of this item. The descriptions are numbered from 1 through 7, where the most favorable description is numbered as 1 and the least favorable description is numbered as 7.

Full Information

First Posted
September 26, 2019
Last Updated
December 7, 2021
Sponsor
Shionogi
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1. Study Identification

Unique Protocol Identification Number
NCT04110054
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
December 8, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough
Keywords
P2X3 receptor antagonist, Refractory chronic cough, S-600918

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-600918 50 mg
Arm Type
Experimental
Arm Description
Participants will receive 50 mg S-600918 orally once a day for 28 days.
Arm Title
S-600918 150 mg
Arm Type
Experimental
Arm Description
Participants will receive 150 mg S-600918 orally once a day for 28 days.
Arm Title
S-600918 300 mg
Arm Type
Experimental
Arm Description
Participants will receive 300 mg S-600918 orally once a day for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to S-600918 orally once a day for 28 days.
Intervention Type
Drug
Intervention Name(s)
S-600918
Other Intervention Name(s)
Sivopixant
Intervention Description
Tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo to S-600918
Intervention Description
Tablets for oral administration
Primary Outcome Measure Information:
Title
Change in Cough at Week 4 Calculated as the Ratio of Number of Coughs per Hour in 24 Hours at Week 4 to Baseline
Description
The number of coughs per hour for 24 hours will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 30%
Description
The number of coughs per hour for 24 hours will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 50%
Description
The number of coughs per hour for 24 hours will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 70%
Description
The number of coughs per hour for 24 hours will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Change in Cough at Week 4 Calculated as the Ratio of the Number of Coughs per Hour While Awake at Week 4 to Baseline
Description
The number of coughs per hour while awake will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 30%
Description
The number of coughs per hour while awake will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 50%
Description
The number of coughs per hour while awake will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 70%
Description
The number of coughs per hour while awake will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Change in Cough at Week 4 Calculated as the Ratio of the Number of Coughs per Hour While Asleep at Week 4 to Baseline
Description
The number of coughs per hour while asleep will be measured using a cough monitor.
Time Frame
Baseline and Week 4
Title
Change from Baseline in Weekly Cough Severity
Description
Cough severity will be assessed by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Time Frame
Baseline and Week 4
Title
Change from Baseline through Day 7 in Daily Cough Severity
Description
Cough severity will be assessed by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Time Frame
Baseline and Day 7
Title
Change from Baseline in Leicester Cough Questionnaire (LCQ)
Description
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient 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; a higher score indicates a better quality of life.
Time Frame
Baseline and Week 4
Title
Percentage of Participants with an Increase in LCQ of ≥ 1.3 points
Description
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient 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; a higher score indicates a better quality of life.
Time Frame
Baseline and Week 4
Title
Change from Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Description
The ICIQ-SF is a patient-reported measure of the severity of urinary incontinence and quality of life (QOL) for those with urinary incontinence. The questionnaire consists of 4 items that evaluate the frequency, severity, and impact of urinary incontinence on QOL. A total score ranging from 0-21 is possible for 3 of the 4 items combined, where a higher score indicates more severe symptoms. The 1 item remaining is not given a score; rather, the patient selects one description out of 8 possible descriptions of this item.
Time Frame
Baseline and Week 4
Title
Change from Baseline in Short Form (36) Health Survey (SF-36)
Description
The SF-36 is a patient-reported measure of overall health status. The questionnaire consists of 8 scaled scores (health concepts) and evaluates vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Scores for each scale range from 0 to 100; the lower the score, the greater the disability.
Time Frame
Baseline and Week 4
Title
Patient Global Impression of Change (PGIC)
Description
The PGIC is a patient-reported measure of overall health status and consists of one item adapted from the Clinical Global Impressions scale. The patient selects one description out of 7 possible descriptions of this item. The descriptions are numbered from 1 through 7, where the most favorable description is numbered as 1 and the least favorable description is numbered as 7.
Time Frame
Week 4

10. Eligibility

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

12. IPD Sharing Statement

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Evaluation of S-600918 in Adults With Refractory Chronic Cough

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