Evaluation of S-600918 in Adults With Refractory Chronic Cough

Last updated: March 1, 2024
Sponsor: Shionogi
Overall Status: Completed

Phase

2

Condition

Chronic Cough

Treatment

Placebo to S-600918

S-600918

Clinical Study ID

NCT04110054
1812VA323
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Having refractory chronic cough (including unexplained chronic cough) for at least 1year.
  • If female and of childbearing potential, agreement to use one of the allowedcontraceptive methods.
  • Capable of giving signed informed consent.

Exclusion

Key Exclusion Criteria:

  • Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes,smokeless cigarettes, vaping); stopped smoking or using potentially irritatinginhalational agents within the last year; or has a smoking history of 20 pack-years ormore.
  • 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 apulmonary 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 ofmarijuana 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 orrequires such treatment.
  • Has a positive serologic test for human immunodeficiency virus (HIV) antigen orantibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
  • If female, pregnant or trying to become pregnant or breastfeeding.

Study Design

Total Participants: 406
Treatment Group(s): 2
Primary Treatment: Placebo to S-600918
Phase: 2
Study Start date:
February 13, 2020
Estimated Completion Date:
December 28, 2020

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  • Fakultní Nemocnice Olomouc

    Olomouc, Czech Republic 779 00
    Czechia

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  • MUDr. I. Čierná-Peterová s.r.o.

    Brandýs nad Labem-Stará Boleslav, 250 01
    Czechia

    Site Not Available

  • Plicní Ambulance Rokycany s.r.o.

    Rokycany, 337 22
    Czechia

    Site Not Available

  • MUDr. Jaroslav Mareš -

    Strakonice, 386 01
    Czechia

    Site Not Available

  • Plicní středisko Teplice s.r.o.

    Teplice, 415 01
    Czechia

    Site Not Available

  • Pneumologie Varnsdorf s.r.o.

    Varnsdorf, 407 47
    Czechia

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  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

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  • Fukui Prefectural Hospital

    Fukui-shi, Fukui 910-8526
    Japan

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

    Fukuoka City, Fukuoka 815-8588
    Japan

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  • Nishi Fukuoka Hospital

    Fukuoka-shi, Fukuoka 819-8555
    Japan

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  • Iizuka Hospital

    Iizuka, Fukuoka 820-8505
    Japan

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  • Fukushima Medical University Hospital

    Fukushima-shi, Fukushima 960-1295
    Japan

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  • Fukushima Medical University Hospital

    Fukushima-shi,, Fukushima 960-1295
    Japan

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    Mizunami-shi, Gifu 509-6134
    Japan

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  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima 735-8585
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  • Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital

    Fukuyama, Hiroshima 7200001
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  • Idaimae Minamiyojo Int Clinic

    Sapporo, Hokkaido 064-0804
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  • Makita Hospital

    Sapporo-city, Hokkaido 001-0901
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  • Nakatani Hospital

    Himeji, Hyogo 672-8064
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  • Kobe University Hospital

    Kobe City, Hyogo 650-0017
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  • Hitachi , Ltd. Hitachinaka General Hospital

    Hitachinaka, Ibaraki 312-0057
    Japan

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    Hitachinaka-shi, Ibaraki 312-0057
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  • National Hospital Organization Ibarakihigashi National Hospital

    Naka-gun, Ibaraki 319-1113
    Japan

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  • Ishikawa Prefectural Central Hospital

    Kanazawa-shi, Ishikawa 9208530
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  • Sakaide City Hospital

    Sakaide-shi, Kagawa 762-8550
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  • Kamei Internal Medicine and Respiratory Clinic

    Takamatsu, Kagawa 761-8073
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  • Fujisawa City Hospital

    Fujisawa, Kanagawa 251-8550
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  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa 252-0392
    Japan

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    Sagamihara-shi, Kanagawa 252-0392
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  • Yokohama City Minato Red Cross Hospital

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    Kyoto-shi, Kyoto 606-8507
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  • Lee's Clinic

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  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai-shi, Osaka 591-8555
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  • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital

    Hamamatsu-shi, Shizuoka 430-8525
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  • Shizuoka General Hospital

    Shizuoka-shi, Shizuoka 420-8527
    Japan

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  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

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  • Nihonbashi Medical & Allergy Clinic

    Chuo-ku, Tokyo 103-0022
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  • Takahashi Medical Clinic

    Kokubunji-shi, Tokyo 185-0014
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  • Senzoku Kokyuuki Allergy Clinic

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    Setagaya-ku,, Tokyo 157-0072
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  • Koukokukai Ebisu Clinic

    Shibuya-shi, Tokyo 150-0013
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  • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

    Shinagawa-ku, Tokyo 140-8522
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  • Kouwakai Kouwa Clinic

    Toshima-ku, Tokyo 170-0003
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  • Shimonoseki City Hospital

    Shimonoseki-shi, Yamaguchi 750-8520
    Japan

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  • Nishi Fukuoka Hospital

    Fukuoka, 819-8555
    Japan

    Site Not Available

  • Nishi Fukuoka Hospital

    Fukuoka-shi, Fukuoka, 819-8555
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima, 960-1295
    Japan

    Site Not Available

  • Tohno Chuo Clinic

    Gifu, 509-6134
    Japan

    Site Not Available

  • Nakatani Hospital

    Himeji-shi, 672-8064
    Japan

    Site Not Available

  • Nakatani Hospital

    Hyōgo, 672-8064
    Japan

    Site Not Available

  • Hitachi , Ltd. Hitachinaka General Hospital

    Ibaraki, 312-0057
    Japan

    Site Not Available

  • Kamei Internal Medicine and Respiratory Clinic

    Kagawa, 761-8073
    Japan

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  • National Hospital Organization Sagamihara National Hospital

    Kanagawa, 252-0392
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  • Nagoya City University Hospital

    Nagoya, Aichi, 467-8602
    Japan

    Site Not Available

  • Lee's Clinic

    Osaka-shi, Osaka, 531-0073
    Japan

    Site Not Available

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara-shi, Kanagawa, 252-0392
    Japan

    Site Not Available

  • Idaimae Minamiyojo Int Clinic

    Sapporo, Hokkaido, 064-0804
    Japan

    Site Not Available

  • KONO Medical Clinic

    Setagaya-ku, Tokyo, 157-0072
    Japan

    Site Not Available

  • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital

    Shizuoka, 430-8525
    Japan

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    Takamatsu-shi, 761-8073
    Japan

    Site Not Available

  • Senzoku Kokyuuki Allergy Clinic

    Tokyo, 145-0063
    Japan

    Site Not Available

  • Shimomoseki City Hospital

    Yamaguchi, 750-8520
    Japan

    Site Not Available

  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

    Yokohama, 223-0059
    Japan

    Site Not Available

  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

    Yokohama-shi,, 223-0059
    Japan

    Site Not Available

  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

    Yokohama-shi, Kanagawa, 223-0059
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    Bialystok, 15-044
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    Site Not Available

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    Bialystok, 15-010
    Poland

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  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796
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    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338
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    Site Not Available

  • Centrum Medyczne Silmedic Sp. z o. o.

    Katowice, 40-282
    Poland

    Site Not Available

  • Gyncentrum Sp. Z o. o.

    Katowice, 40-851
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  • Diamond Clinic

    Krakow, 31-559
    Poland

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    Lodz, 90-141
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    Site Not Available

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

    Ostrowiec Swietokrzyski, 27-400
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  • Centrum Alergologii Teresa Hofman Sp. Z o.o.

    Poznan, 60-214
    Poland

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  • RCMed Oddz. Sochaczew

    Sochaczew, 96-500
    Poland

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  • Centrum Medyczne Lucyna Andrzej Dymek

    Strzelce Opolskie, 47-100
    Poland

    Site Not Available

  • Alergo-Med Specjalistyczna Przychodnia Lekarska

    Tarnow, 33-100
    Poland

    Site Not Available

  • Chernihiv City Hospital #2, Therapy Department

    Chernihiv, 14034
    Ukraine

    Site Not Available

  • City Clinical Hospital #13

    Kharkiv, 61124
    Ukraine

    Site Not Available

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

    Kharkiv, 61058
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  • 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

    Site Not Available

  • City Clinical Hospital

    Kharkivs'ke, 61124
    Ukraine

    Site Not Available

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

    Kherson, 73000
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    Kyiv, 03115
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    Site Not Available

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    Kyiv, 03049
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    Site Not Available

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    Kyiv, 02002
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    Site Not Available

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    Kyiv, 03037
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    Kyiv, 01023
    Ukraine

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    Kyiv, 02232
    Ukraine

    Site Not Available

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

    Kyiv, 02232
    Ukraine

    Site Not Available

  • National Institute of Phthisiology and Pulmonology, Department of Pulmonology

    Kyiv, 03038
    Ukraine

    Site Not Available

  • 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

    Site Not Available

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

    Lutsk, 43005
    Ukraine

    Site Not Available

  • The 1st City Clinical Hospital of Poltava City Council

    Poltava, 36039
    Ukraine

    Site Not Available

  • 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

    Site Not Available

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

    Vinnytsya, 21001
    Ukraine

    Site Not Available

  • Respiratory Clinical Trials

    Cottingham, East Yorkshire HU16 5JQ
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, Greater Manchester M23 9LT
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  • MeDiNova South London Quality Research Site

    Sid Cup, Kent DA14 6LT
    United Kingdom

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  • MeDiNova South London Quality Research Site

    Sidcup, Kent DA14 6LT
    United Kingdom

    Site Not Available

  • BMI Bishops Wood Hospital

    Northwood, Middlesex HA6 2JW
    United Kingdom

    Site Not Available

  • MeDiNova North London Quality Research Site

    Northwood, Middlesex HA6 2RN
    United Kingdom

    Site Not Available

  • Medinova Research Northamptonshire Quality Research Site

    Corby, Northamptonshire NN18 9EZ
    United Kingdom

    Site Not Available

  • Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital

    North Shields, Northumberland NE29 8NH
    United Kingdom

    Site Not Available

  • Medinova Yorkshire Quality Research Site

    Bradford, West Yorkshire 8D18 3SA
    United Kingdom

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  • Belfast City Hospital

    Belfast, BT9 7AB
    United Kingdom

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  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

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  • West Walk Surgery

    Yate, BS37 4AX
    United Kingdom

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  • Research Solutions of Arizona

    Litchfield Park, Arizona 85340
    United States

    Site Not Available

  • Pulmonary Associates, PA

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Southern California Institute For Respiratory Diseases, Inc.

    Los Angeles, California 90048
    United States

    Site Not Available

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

    Mission Viejo, California 92691
    United States

    Site Not Available

  • California Medical Research Associates, Inc.

    Northridge, California 91324
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  • Center for Clinical Trials, LLC

    Paramount, California 90723
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    Site Not Available

  • Institute of HealthCare Assessment, Inc.

    San Diego, California 92120
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  • Sher Allergy Specialist/Center for Cough

    Largo, Florida 33778
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    Site Not Available

  • Medical Research Of Central Florida, LLC

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Lenus Research & Medical Group, LLC

    Sweetwater, Florida 33172
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    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
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    Site Not Available

  • Sneeze, Wheeze, & Itch Associates, LLC

    Normal, Illinois 61761
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    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
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    Site Not Available

  • University of Kansas Medical Center-Hospital

    Kansas City, Kansas 66160
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    Site Not Available

  • Abraham Research PLLC

    Fort Mitchell, Kentucky 41017
    United States

    Site Not Available

  • Shionogi Research Site

    Bangor, Maine 04401
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    Site Not Available

  • St. Joseph's Hospital

    Bangor, Maine 04401
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  • Minnesota Lung Center

    Edina, Minnesota 55435
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  • Mayo Clinic Pulmonary Clinical Research Unit

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic, Division of Pulmonary and Critical Care Medicine

    Rochester, Minnesota 55905
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    Site Not Available

  • Minnesota Lung Center

    Woodbury, Minnesota 55125
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    Site Not Available

  • University of Missouri Hospital - Clinical Research Center

    Columbia, Missouri 65212
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    Site Not Available

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

    Columbia, Missouri 65201
    United States

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

    Columbia, Missouri 65201
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  • Associated Specialists in Medicine, PC

    Saint Louis, Missouri 63141
    United States

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  • Clayton Sleep Institute, LLC

    Saint Louis, Missouri 63123
    United States

    Site Not Available

  • The Clinical Research Center, LLC

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
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  • Creighton University Clinical Research Office

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Atlantic Research Center, LLC

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • American Health Research Inc

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Clinical Research of Gastonia

    Gastonia, North Carolina 28504
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    Site Not Available

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103
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    Site Not Available

  • New Horizons Clinical Research

    Cincinnati, Ohio 45242
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    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
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  • Northwest Research Center

    Portland, Oregon 97202
    United States

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  • Clinical Research Associaes of Central PA, LLC

    DuBois, Pennsylvania 15801
    United States

    Site Not Available

  • Clinical Research Associates of Central PA, LLC

    DuBois, Pennsylvania 15801
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  • AAPRI Clinical Research Institute

    Warwick, Rhode Island 02886
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    Greenville, South Carolina 29607
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  • Allergy Asthma Research Institute

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    Williamsburg, Virginia 23188
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  • Allergy, Asthma & Sinus Center, S.C.

    Greenfield, Wisconsin 53228
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