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Chronic CoughPhase 2NCT04110054

Evaluation of S-600918 in Adults With Refractory Chronic Cough

A Phase 2 study testing S-600918 in people with Chronic Cough, run by Shionogi at 136 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Cough
What is being tested?
S-600918
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
136 sitesin 6 countries
Study dates
13 Feb 2020to 28 Dec 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

136 sites in 6 countries.

136 sites in 6 countries

United States51 sites

  • Shionogi Research Site

    Bangor, Maine, 04401

  • St. Joseph's Hospital

    Bangor, Maine, 04401

  • American Health Research Inc

    Charlotte, North Carolina, 28207

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

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

    Columbia, Missouri, 65201

  • University of Missouri Hospital and Clinics, Hearing and Balance Center

    Columbia, Missouri, 65201

  • University of Missouri Hospital - Clinical Research Center

    Columbia, Missouri, 65212

  • Pharmaceutical Research & Consulting, Inc

    Dallas, Texas, 75231

  • Intermountain Clinical Research

    Draper, Utah, 84020

  • Clinical Research Associates of Central PA, LLC

    DuBois, Pennsylvania, 15801

  • Minnesota Lung Center

    Edina, Minnesota, 55435

  • Abraham Research PLLC

    Fort Mitchell, Kentucky, 41017

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28504

  • Allergy, Asthma & Sinus Center, S.C.

    Greenfield, Wisconsin, 53228

  • ADAC Research, PA

    Greenville, South Carolina, 29607

  • MCA Research

    Houston, Texas, 77084

  • University of Kansas Medical Center-Hospital

    Kansas City, Kansas, 66160

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Sher Allergy Specialist/Center for Cough

    Largo, Florida, 33778

  • Medical Research Of Central Florida, LLC

    Leesburg, Florida, 34748

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • Southern California Institute For Respiratory Diseases, Inc.

    Los Angeles, California, 90048

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069

  • Allergy & Asthma Associates of Southern California dba Southern California Research

    Mission Viejo, California, 92691

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • Sneeze, Wheeze, & Itch Associates, LLC

    Normal, Illinois, 61761

  • California Medical Research Associates, Inc.

    Northridge, California, 91324

  • Atlantic Research Center, LLC

    Ocean City, New Jersey, 07712

  • Creighton University Clinical Research Office

    Omaha, Nebraska, 68124

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • Pulmonary Associates, PA

    Phoenix, Arizona, 85032

  • Northwest Research Center

    Portland, Oregon, 97202

  • Mayo Clinic Pulmonary Clinical Research Unit

    Rochester, Minnesota, 55905

  • Mayo Clinic, Division of Pulmonary and Critical Care Medicine

    Rochester, Minnesota, 55905

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Institute of HealthCare Assessment, Inc.

    San Diego, California, 92120

  • Clayton Sleep Institute, LLC

    St Louis, Missouri, 63123

  • Associated Specialists in Medicine, PC

    St Louis, Missouri, 63141

  • The Clinical Research Center, LLC

    St Louis, Missouri, 63141

  • Lenus Research & Medical Group, LLC

    Sweetwater, Florida, 33172

  • Alliance for Multispecialty Research

    Tempe, Arizona, 85283

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Allergy and Asthma Care of Waco

    Waco, Texas, 76712

  • Allergy Asthma Research Institute

    Waco, Texas, 76712

  • AAPRI Clinical Research Institute

    Warwick, Rhode Island, 02886

  • Tidewater Physicians Multispecialty Group Clinical Research

    Williamsburg, Virginia, 23188

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

  • Minnesota Lung Center

    Woodbury, Minnesota, 55125

Other trials in United States

Japan38 sites

  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima, 735-8585

  • Nihonbashi Medical & Allergy Clinic

    Chuo-ku, Tokyo, 103-0022

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Fujisawa City Hospital

    Fujisawa, Kanagawa, 251-8550

  • Fukui Prefectural Hospital

    Fukui-shi, Fukui, 910-8526

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

    Fukuoka, Fukuoka, 815-8588

  • Nishi Fukuoka Hospital

    Fukuoka, Fukuoka, 819-8555

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital

    Fukuyama, Hiroshima, 7200001

  • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital

    Hamamatsu, Shizuoka, 430-8525

  • Nakatani Hospital

    Himeji, Hyōgo, 672-8064

  • Hitachi, Ltd. Hitachinaka General Hospital

    Hitachi-Naka, Ibaraki, 312-0057

  • Iizuka Hospital

    Iizuka, Fukuoka, 820-8505

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 9208530

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Takahashi Medical Clinic

    Kokubunji-shi, Tokyo, 185-0014

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Tohno Chuo Clinic

    Mizunami-shi, Gifu, 509-6134

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Ibarakihigashi National Hospital

    Naka-gun, Ibaraki, 319-1113

  • Lee's Clinic

    Osaka, Osaka, 531-0073

  • Senzoku Kokyuuki Allergy Clinic

    Ōta-ku, Tokyo, 145-0063

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara-shi, Kanagawa, 252-0392

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai-shi, Osaka, 591-8555

  • Sakaide City Hospital

    Sakaide-shi, Kagawa-ken, 762-8550

  • Makita Hospital

    Sapporo, Hokkaido, 001-0901

  • Idaimae Minamiyojo Int Clinic

    Sapporo, Hokkaido, 064-0804

  • Tohoku Rosai Hospital

    Sendai, Miyagi, 981-8563

  • Yoga Allergy Clinic

    Setagaya City, Tokyo, 158-0097

  • KONO Medical Clinic

    Setagaya-ku, Tokyo, 157-0072

  • Koukokukai Ebisu Clinic

    Shibuya-shi, Tokyo, 150-0013

  • Shimonoseki City Hospital

    Shimonoseki-shi, Yamaguchi, 750-8520

  • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

    Shinagawa-ku, Tokyo, 140-8522

  • Shizuoka General Hospital

    Shizuoka, Shizuoka, 420-8527

  • Kamei Internal Medicine and Respiratory Clinic

    Takamatsu, Kagawa-ken, 761-8073

  • Kouwakai Kouwa Clinic

    Toshima-ku, Tokyo, 170-0003

  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

    Yokohama, Kanagawa, 223-0059

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-8682

Other trials in Japan

Ukraine17 sites

  • Chernihiv City Hospital #2, Therapy Department

    Chernihiv, 14034

  • 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

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

    Kharkiv, 61058

  • City Clinical Hospital #13

    Kharkiv, 61124

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

    Kherson, 73000

  • Medical Center of LLC Medical Clinic Blagomed

    Kyiv, 01023

  • Medical Center of Edelweiss Medics LLC , Treatment and Prevention Department

    Kyiv, 02002

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

    Kyiv, 02232

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

    Kyiv, 03037

  • National Institute of Phthisiology and Pulmonology, Department of Pulmonology

    Kyiv, 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, 03038

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

    Kyiv, 03049

  • 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

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

    Lutsk, 43005

  • The 1st City Clinical Hospital of Poltava City Council

    Poltava, 36039

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

    Vinnytsia, 21001

  • 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

Other trials in Ukraine

Poland13 sites

  • Prywatny Gabinet lnternistyczno-Alergologiczny

    Bialystok, 15-010

  • Centrum Medycyny Oddechowej Mroz sp. j.

    Bialystok, 15-044

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • Centrum Medyczne Silmedic Sp. z o. o.

    Katowice, 40-282

  • Gyncentrum Sp. Z o. o.

    Katowice, 40-851

  • Diamond Clinic

    Krakow, 31-559

  • Poradnia Alergologiczna SPZOZ USK nr 1 UM w Lodzi

    Lodz, 90-141

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

    Ostrowiec Świętokrzyski, 27-400

  • Centrum Alergologii Teresa Hofman Sp. Z o.o.

    Poznan, 60-214

  • RCMed Oddz. Sochaczew

    Sochaczew, 96-500

  • Centrum Medyczne Lucyna Andrzej Dymek

    Strzelce Opolskie, 47-100

  • Alergo-Med Specjalistyczna Przychodnia Lekarska

    Tarnów, 33-100

Other trials in Poland

United Kingdom11 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Medinova Yorkshire Quality Research Site

    Bradford, West Yorkshire, 8D18 3SA

  • Medinova Research Northamptonshire Quality Research Site

    Corby, Northamptonshire, NN18 9EZ

  • Respiratory Clinical Trials

    Cottingham, East Yorkshire, HU16 5JQ

  • Kings College Hospital

    London, SE5 9RS

  • Wythenshawe Hospital

    Manchester, Greater Manchester, M23 9LT

  • Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital

    North Shields, Northumberland, NE29 8NH

  • BMI Bishops Wood Hospital

    Northwood, Middlesex, HA6 2JW

  • MeDiNova North London Quality Research Site

    Northwood, Middlesex, HA6 2RN

  • MeDiNova South London Quality Research Site

    Sidcup, Kent, DA14 6LT

  • West Walk Surgery

    Yate, BS37 4AX

Other trials in United Kingdom

Czechia6 sites

  • MUDr. I. Čierná-Peterová s.r.o.

    Brandýs nad Labem-Stará Boleslav, 250 01

  • Fakultní Nemocnice Olomouc

    Olomouc, Czech Republic, 779 00

  • Plicní Ambulance Rokycany s.r.o.

    Rokycany, 337 22

  • MUDr. Jaroslav Mareš -

    Strakonice, 386 01

  • Plicní středisko Teplice s.r.o.

    Teplice, 415 01

  • Pneumologie Varnsdorf s.r.o.

    Varnsdorf, 407 47

Other trials in Czechia

About this study

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

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
Being tested
S-600918, Placebo to S-600918
Keywords
P2X3 receptor antagonist, Refractory chronic cough, S-600918
Medical subject headings
Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-600918Drug

    Also called Sivopixant

    Tablets for oral administration

  • Placebo to S-600918Drug

    Tablets for oral administration

Study groups in NCT04110054
Study groupRoleWhat they receive
S-600918 50 mgExperimentalParticipants will receive 50 mg S-600918 orally once a day for 28 days.
Receives: Drug: S-600918
S-600918 150 mgExperimentalParticipants will receive 150 mg S-600918 orally once a day for 28 days.
Receives: Drug: S-600918
S-600918 300 mgExperimentalParticipants will receive 300 mg S-600918 orally once a day for 28 days.
Receives: Drug: S-600918
PlaceboPlacebo comparatorParticipants will receive placebo to S-600918 orally once a day for 28 days.
Receives: Drug: Placebo to S-600918

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 4

Secondary outcomes (10)

  1. 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.

    Measured: Baseline to Week 4

  2. 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.

    Measured: Baseline to Week 4

  3. 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.

    Measured: Baseline to Week 4

  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.

    Measured: Baseline to Week 4

  5. 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.

    Measured: Baseline to Week 4

  6. 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.

    Measured: Baseline to Week 4

  7. 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.

    Measured: Baseline to Week 4

  8. 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.

    Measured: Baseline to Week 4

  9. 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.

    Measured: Baseline to Week 4

  10. 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.

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start13 Feb 2020
  3. Primary completion8 Dec 2020
  4. Study completion28 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110054
Sponsor's protocol ID
1812VA323
Status last verified
Mar 2024
First submitted
26 Sep 2019
Last updated
27 Mar 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36512069

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-600918 in people with Chronic Cough, run by Shionogi at 136 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, Japan, Ukraine, Poland, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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