Evaluation of S-600918 in Adults With Refractory Chronic Cough

NCT04110054 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1812VA323
• Study Type: interventional
• Target: 406
• Locations: 6 countries
• Sites: 136

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.

Conditions

Chronic Cough

Keywords

P2X3 receptor antagonist; Refractory chronic cough; S-600918

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment

  Baseline to Week 4

• Percent Change in Number of Coughs Per Hour While Awake Following 4 Weeks of Study Treatment

  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

  Baseline to Week 4

• Percent Change in Number of Coughs Per Hour While Asleep Following 4 Weeks of Study Treatment

  Baseline to Week 4

• Change From Baseline in Weekly Cough Severity Following 4 Weeks of Study Treatment

  Baseline to Week 4

Study Arms (4)

S-600918 50 mg

EXPERIMENTAL

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

Drug: S-600918

S-600918 150 mg

EXPERIMENTAL

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

Drug: S-600918

S-600918 300 mg

EXPERIMENTAL

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

Drug: S-600918

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo to S-600918

Interventions

S-600918 DRUG

Tablets for oral administration

Also known as: Sivopixant

S-600918 150 mg; S-600918 300 mg; S-600918 50 mg

Placebo to S-600918 DRUG

Tablets for oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (136)

Research Solutions of Arizona

Litchfield Park, Arizona, 85340, United States

Location

Pulmonary Associates, PA

Phoenix, Arizona, 85032, United States

Location

Alliance for Multispecialty Research

Tempe, Arizona, 85283, United States

Location

Southern California Institute For Respiratory Diseases, Inc.

Los Angeles, California, 90048, United States

Location

Allergy & Asthma Associates of Southern California dba Southern California Research

Mission Viejo, California, 92691, United States

Location

California Medical Research Associates, Inc.

Northridge, California, 91324, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

Institute of HealthCare Assessment, Inc.

San Diego, California, 92120, United States

Location

Sher Allergy Specialist/Center for Cough

Largo, Florida, 33778, United States

Location

Medical Research Of Central Florida, LLC

Leesburg, Florida, 34748, United States

Location

Lenus Research & Medical Group, LLC

Sweetwater, Florida, 33172, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

University of Kansas Medical Center-Hospital

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Abraham Research PLLC

Fort Mitchell, Kentucky, 41017, United States

Location

Shionogi Research Site

Bangor, Maine, 04401, United States

Location

St. Joseph's Hospital

Bangor, Maine, 04401, United States

Location

Minnesota Lung Center

Edina, Minnesota, 55435, United States

Location

Mayo Clinic Pulmonary Clinical Research Unit

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic, Division of Pulmonary and Critical Care Medicine

Rochester, Minnesota, 55905, United States

Location

Minnesota Lung Center

Woodbury, Minnesota, 55125, United States

Location

University of Missouri Hospital and Clinics, ENT & Allergy Center of Missouri

Columbia, Missouri, 65201, United States

Location

University of Missouri Hospital and Clinics, Hearing and Balance Center

Columbia, Missouri, 65201, United States

Location

University of Missouri Hospital - Clinical Research Center

Columbia, Missouri, 65212, United States

Location

Clayton Sleep Institute, LLC

St Louis, Missouri, 63123, United States

Location

Associated Specialists in Medicine, PC

St Louis, Missouri, 63141, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

Creighton University Clinical Research Office

Omaha, Nebraska, 68124, United States

Location

Atlantic Research Center, LLC

Ocean City, New Jersey, 07712, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

American Health Research Inc

Charlotte, North Carolina, 28207, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28504, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, 15801, United States

Location

AAPRI Clinical Research Institute

Warwick, Rhode Island, 02886, United States

Location

ADAC Research, PA

Greenville, South Carolina, 29607, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Pharmaceutical Research & Consulting, Inc

Dallas, Texas, 75231, United States

Location

MCA Research

Houston, Texas, 77084, United States

Location

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Allergy and Asthma Care of Waco

Waco, Texas, 76712, United States

Location

Allergy Asthma Research Institute

Waco, Texas, 76712, United States

Location

Intermountain Clinical Research

Draper, Utah, 84020, United States

Location

Tidewater Physicians Multispecialty Group Clinical Research

Williamsburg, Virginia, 23188, United States

Location

Allergy, Asthma & Sinus Center, S.C.

Greenfield, Wisconsin, 53228, United States

Location

Fakultní Nemocnice Olomouc

Olomouc, Czech Republic, 779 00, Czechia

Location

MUDr. I. Čierná-Peterová s.r.o.

Brandýs nad Labem-Stará Boleslav, 250 01, Czechia

Location

Plicní Ambulance Rokycany s.r.o.

Rokycany, 337 22, Czechia

Location

MUDr. Jaroslav Mareš -

Strakonice, 386 01, Czechia

Location

Plicní středisko Teplice s.r.o.

Teplice, 415 01, Czechia

Location

Pneumologie Varnsdorf s.r.o.

Varnsdorf, 407 47, Czechia

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukui Prefectural Hospital

Fukui-shi, Fukui, 910-8526, Japan

Location

Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuoka, Fukuoka, 815-8588, Japan

Location

Nishi Fukuoka Hospital

Fukuoka, Fukuoka, 819-8555, Japan

Location

Iizuka Hospital

Iizuka, Fukuoka, 820-8505, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Tohno Chuo Clinic

Mizunami-shi, Gifu, 509-6134, Japan

Location

Mazda Hospital of Mazda Motor Corporation

Aki-gun, Hiroshima, 735-8585, Japan

Location

Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital

Fukuyama, Hiroshima, 7200001, Japan

Location

Makita Hospital

Sapporo, Hokkaido, 001-0901, Japan

Location

Idaimae Minamiyojo Int Clinic

Sapporo, Hokkaido, 064-0804, Japan

Location

Nakatani Hospital

Himeji, Hyōgo, 672-8064, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Hitachi, Ltd. Hitachinaka General Hospital

Hitachi-Naka, Ibaraki, 312-0057, Japan

Location

National Hospital Organization Ibarakihigashi National Hospital

Naka-gun, Ibaraki, 319-1113, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 9208530, Japan

Location

Sakaide City Hospital

Sakaide-shi, Kagawa-ken, 762-8550, Japan

Location

Kamei Internal Medicine and Respiratory Clinic

Takamatsu, Kagawa-ken, 761-8073, Japan

Location

Fujisawa City Hospital

Fujisawa, Kanagawa, 251-8550, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

Yokohama, Kanagawa, 223-0059, Japan

Location

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 231-8682, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Tohoku Rosai Hospital

Sendai, Miyagi, 981-8563, Japan

Location

Lee's Clinic

Osaka, Osaka, 531-0073, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai-shi, Osaka, 591-8555, Japan

Location

Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka, 430-8525, Japan

Location

Shizuoka General Hospital

Shizuoka, Shizuoka, 420-8527, Japan

Location

Nihonbashi Medical & Allergy Clinic

Chuo-ku, Tokyo, 103-0022, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Takahashi Medical Clinic

Kokubunji-shi, Tokyo, 185-0014, Japan

Location

Senzoku Kokyuuki Allergy Clinic

Ōta-ku, Tokyo, 145-0063, Japan

Location

Yoga Allergy Clinic

Setagaya City, Tokyo, 158-0097, Japan

Location

KONO Medical Clinic

Setagaya-ku, Tokyo, 157-0072, Japan

Location

Koukokukai Ebisu Clinic

Shibuya-shi, Tokyo, 150-0013, Japan

Location

Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

Shinagawa-ku, Tokyo, 140-8522, Japan

Location

Kouwakai Kouwa Clinic

Toshima-ku, Tokyo, 170-0003, Japan

Location

Shimonoseki City Hospital

Shimonoseki-shi, Yamaguchi, 750-8520, Japan

Location

Prywatny Gabinet lnternistyczno-Alergologiczny

Bialystok, 15-010, Poland

Location

Centrum Medycyny Oddechowej Mroz sp. j.

Bialystok, 15-044, Poland

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, 85-796, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Centrum Medyczne Silmedic Sp. z o. o.

Katowice, 40-282, Poland

Location

Gyncentrum Sp. Z o. o.

Katowice, 40-851, Poland

Location

Diamond Clinic

Krakow, 31-559, Poland

Location

Poradnia Alergologiczna SPZOZ USK nr 1 UM w Lodzi

Lodz, 90-141, Poland

Location

Ostrowieckie CM S.C. A. Olech-Cudzik, K. Cudzik

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Centrum Alergologii Teresa Hofman Sp. Z o.o.

Poznan, 60-214, Poland

Location

RCMed Oddz. Sochaczew

Sochaczew, 96-500, Poland

Location

Centrum Medyczne Lucyna Andrzej Dymek

Strzelce Opolskie, 47-100, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska

Tarnów, 33-100, Poland

Location

Chernihiv City Hospital #2, Therapy Department

Chernihiv, 14034, Ukraine

Location

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, 61007, Ukraine

Location

Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Pulmonary-Allergological Department with Immunological and Therapeutic Beds

Kharkiv, 61058, Ukraine

Location

City Clinical Hospital #13

Kharkiv, 61124, Ukraine

Location

Communal Non-profit Enterprise "Kherson City Clinical Hospital named after Ye. Ye. Karabelesh" of the Kherson City Council, Pulmonary Therapeutic Department

Kherson, 73000, Ukraine

Location

Medical Center of LLC Medical Clinic Blagomed

Kyiv, 01023, Ukraine

Location

Medical Center of Edelweiss Medics LLC , Treatment and Prevention Department

Kyiv, 02002, Ukraine

Location

Municipal Non-commercial Enterprise "Consultative-Diagnostics Center" of Desnyanskyi District of Kyiv, Therapy Department

Kyiv, 02232, Ukraine

Location

Medical Center of LLC Medbud-Clinic, Treatment and Prevention Department

Kyiv, 03037, Ukraine

Location

National Institute of Phthisiology and Pulmonology, Department of Pulmonology

Kyiv, 03038, Ukraine

Location

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, 03038, Ukraine

Location

Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Department of Pulmonology

Kyiv, 03049, Ukraine

Location

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, 03115, Ukraine

Location

Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Pulmonology Department

Lutsk, 43005, Ukraine

Location

The 1st City Clinical Hospital of Poltava City Council

Poltava, 36039, Ukraine

Location

Small Business Private Enterprise Medical Centre "Pulse", Therapeutic Department

Vinnytsia, 21001, Ukraine

Location

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, 21018, Ukraine

Location

Respiratory Clinical Trials

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Wythenshawe Hospital

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

MeDiNova South London Quality Research Site

Sidcup, Kent, DA14 6LT, United Kingdom

Location

BMI Bishops Wood Hospital

Northwood, Middlesex, HA6 2JW, United Kingdom

Location

MeDiNova North London Quality Research Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Medinova Research Northamptonshire Quality Research Site

Corby, Northamptonshire, NN18 9EZ, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital

North Shields, Northumberland, NE29 8NH, United Kingdom

Location

Medinova Yorkshire Quality Research Site

Bradford, West Yorkshire, 8D18 3SA, United Kingdom

Location

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

West Walk Surgery

Yate, BS37 4AX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36512069 DERIVED

MeSH Terms

Conditions

Chronic Cough

Interventions

sivopixant

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi USA

shionogiclintrialsadmin@shionogi.com

800-849-9707

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: February 13, 2020
• Primary Completion: December 8, 2020
• Study Completion: December 28, 2020
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Locations

US (51); PL (13); JP (38); CZ (6); UA (17); GB (11)