Skuteczność i bezpieczeństwo Gefapixant (MK-7264) u dorosłych absolwentów z niedawnym początkiem przewlekłym przewlekle kaszlu (MK-7264-043)

Randomizowane, podwójnie zaślepione, kontrolowane placebo, wieloośrodkowe badanie fazy 3b w celu oceny przełożenia i bezpieczeństwa Gefapixant u dorosłych uczniów z niedawnym początkiem przewlekłego kaszlu

Sponsorzy

Główny sponsor: Merck Sharp & Dohme Corp.

Źródło Merck Sharp & Dohme Corp.
Krótkie podsumowanie

Celem tego badania jest ocena decyzji i bezpieczeństwa gefapiksantu w uczestnicy, u których niedawno wystąpił przewlekły kaszel (czas trwania> 8 tygodni po wystąpieniu kaszlu objawy) dla

Ogólny stan Rekrutacyjny
Data rozpoczęcia 2020-05-21
Data zakończenia 2021-09-16
Podstawowa data ukończenia 2021-09-16
Faza Faza 3
Typ studiów Interwencjonalne
Wynik podstawowy
Pomiar Ramy czasowe
Zmiana w wartości do wartości wyjściowej w kwestionariuszu kwestionariusza Leicester Cough Questionnaire (LCQ) w okresie 12 Punkt wyjściowy, tydzień 12
Wynik drugorzędny
Pomiar Ramy czasowe
Change from baseline in the Cough Severity Visual Analog Scale (VAS) score at Week 12 Baseline, Week 12
Odsetek uczestników z co najmniej jednego zdarzeniem niepożądanym (AE) Czy ~ 14 tygodnia
Odsetek uczniów, którzy zaprzestali znieczulonego lęku z powodu złego zdarzenia Czy 12 tygodnia
Rekrutacja 414
Stan: schorzenie
Interwencja

Rodzaj interwencji: Drug

Nazwa interwencji: Gefapixant

Opis: Administered twice daily as an oral tablet of 45 mg

Etykieta grupy ramion: Gefapixant

Inna nazwa: MK-7264

Rodzaj interwencji: Lek

Nazwa interwencji: Placebo

Opis: Podawany dwa razy dziennie jako doustna tabletka placebo odpowiadająca gefapiksantowi

Etykieta grupy ramion: Placebo

Kwalifikowalność

Kryteria:

Kryteria a: - RTG klatki piersiowej lub komputerowy skan topografii (TK) klatki piersiowej, klatki piersiowej po wystąpienie wariantu kaszlu, ale przed rozpoznaniem kaszlu przewlekłego wymaga konsultacje ze Sponsorem w celu, czy dopuszcza się sprawdzić do badania - Ma przewlekły kaszel (trwający> 8 tygodni od wystąpienia górnego kaszlu) przez

Płeć:

Wszystko

Minimalny wiek:

18 lat

Maksymalny wiek:

Nie dotyczy

Zdrowi wolontariusze:

Nie

Ogólnie urzędnik
Nazwisko Rola Przynależność
Medical Director Study Director Merck Sharp & Dohme Corp.
Ogólny kontakt

Nazwisko: Toll Free Number

Telefon: 1-888-577-8839

E-mail: [email protected]

Lokalizacja
Obiekt: Status:
Pulmonary Associates, PA ( Site 0016) | Phoenix, Arizona, 85032, United States Completed
Center for Clinical Trials, LLC ( Site 0035) | Paramount, California, 90723, United States Completed
Springfield Clinic, LLP ( Site 0018) | Springfield, Illinois, 62703, United States Completed
Chesapeake Clinical Research, Inc ( Site 0037) | White Marsh, Maryland, 21162, United States Recruiting Study Coordinator 410-931-1966
Albuquerque Clinical Trials ( Site 0030) | Albuquerque, New Mexico, 87102, United States Recruiting Study Coordinator 505-224-7407
Montefiore Einstein Center ( Site 0022) | Bronx, New York, 10461, United States Completed
American Health Research ( Site 0047) | Charlotte, North Carolina, 28277, United States Active, not recruiting
Clinical Research Institute of Southern Oregon, PC ( Site 0028) | Medford, Oregon, 97504, United States Completed
Northwest Research Center ( Site 0039) | Portland, Oregon, 97202, United States Recruiting Study Coordinator 503-238-6233
AAPRI Clinical Research Institute ( Site 0051) | Lincoln, Rhode Island, 02865, United States Completed
Allergic Disease and Asthma Center ( Site 0027) | Greenville, South Carolina, 29607, United States Recruiting Study Coordinator 8646273800221
Diagnostics Research Group ( Site 0021) | San Antonio, Texas, 78229, United States Completed
Allergy & Asthma Center ( Site 0001) | Waco, Texas, 76712, United States Recruiting Study Coordinator 254-741-8151
Tidewater Physician Multispecialty Group, PC ( Site 0048) | Williamsburg, Virginia, 23188, United States Recruiting Study Coordinator 757-707-3999
Bellingham Asthma & Allergy ( Site 0011) | Bellingham, Washington, 98225, United States Recruiting Study Coordinator 360-733-5733
Recherche GCP Research ( Site 0802) | Montreal, Quebec, H1M 1B1, Canada Recruiting Study Coordinator 5147878891x5258
Diex Recherche Quebec Inc ( Site 0805) | Quebec, G1N 4V3, Canada Recruiting Study Coordinator 4186144142
Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800) | Quebec, G1V 4W2, Canada Recruiting Study Coordinator 4186597741
Fundacion Centro de Investigacion Clinica CIC ( Site 0401) | Medellin, Antioquia, 050021, Colombia Recruiting Study Coordinator +573012861610
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408) | Medellin, Antioquia, 050036, Colombia Recruiting Study Coordinator +57 3122957048
Healthy Medical Center S.A.S ( Site 0404) | Zipaquira, Cundinamarca, 250252, Colombia Recruiting Study Coordinator +573108697983
MedPlus Medicina Prepagada S.A. ( Site 0402) | Bogota, Distrito Capital De Bogota, 110221, Colombia Recruiting Study Coordinator +573133503273
Centro Especializado en Enfermedades Pulmonares. ( Site 0410) | Bogota, Distrito Capital De Bogota, 111831, Colombia Recruiting Study Coordinator +573163074224
Instituto Neumologico del Oriente ( Site 0403) | Floridablanca, Santander, 681004, Colombia Recruiting Study Coordinator 573187887568
Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910) | Marburg, Hessen, 35037, Germany Recruiting Study Coordinator +496421270723
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917) | Neu-Isenburg, Hessen, 63263, Germany Recruiting Study Coordinator 00496102809710
Pneumologicum im Suedstadtforum ( Site 0916) | Hannover, Niedersachsen, 30173, Germany Recruiting Study Coordinator +495111691755
Pneumologisches Studienzentrum ( Site 0911) | Berlin, 10969, Germany Recruiting Study Coordinator +4930259393817
Celan SA ( Site 0500) | Guatemala, 01010, Guatemala Recruiting Study Coordinator +50252012851
Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504) | Guatemala, 01010, Guatemala Recruiting Study Coordinator +50252086402
Clinica Medica Especializada en Neumologia ( Site 0502) | Guatemala, 01011, Guatemala Recruiting Study Coordinator +50255135640
Private Clinic ( Site 0505) | Guatemala, 01011, Guatemala Recruiting Study Coordinator +50252045740
Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503) | Guatemala, 01015, Guatemala Recruiting Study Coordinator +50223857431
Instituto De Alergias y Enfermedades Respiratorias ( Site 0501) | Guatemala, 01015, Guatemala Recruiting Study Coordinator +50223857591
Wonju Severance Christian Hospital ( Site 1502) | Wonju-si, Kang-won-do, 26426, Korea, Republic of Recruiting Study Coordinator +82-33-741-0540
Seoul National University Hospital ( Site 1501) | Seoul, 03080, Korea, Republic of Recruiting Study Coordinator +82220722971
Severance Hospital Yonsei University Health System ( Site 1503) | Seoul, 03722, Korea, Republic of Recruiting Study Coordinator +82-2-2228-1961
Konkuk University Medical Center ( Site 1504) | Seoul, 05030, Korea, Republic of Recruiting Study Coordinator +82220305076
Asan Medical Center ( Site 1505) | Seoul, 05505, Korea, Republic of Recruiting Study Coordinator +82632501664
Clinica Ricardo Palma ( Site 0601) | San Isidro, Lima, 15036, Peru Recruiting Study Coordinator +51993456447
Asociacion Civil por la Salud ( Site 0602) | Lima, 15046, Peru Recruiting Study Coordinator +51996495845
Hospital Nacional Arzobispo Loayza ( Site 0607) | Lima, 15082, Peru Recruiting Study Coordinator +51992757990
Clinica Belen ( Site 0604) | Piura, 20001, Peru Recruiting Study Coordinator +5173969417625
Centrum Medyczne Pratia Bydgoszcz ( Site 1206) | Bydgoszcz, Kujawsko-pomorskie, 85-796, Poland Recruiting Study Coordinator +48734120500
NZOZ CENTRUM ALERGOLOGII ( Site 1207) | Lublin, Lubelskie, 20-552, Poland Recruiting Study Coordinator 814628882
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203) | Krakow, Malopolskie, 30-033, Poland Recruiting Study Coordinator +43608623915
RCMed ( Site 1202) | Sochaczew, Mazowieckie, 96-500, Poland Recruiting Study Coordinator +48792000477
Centrum Medyczne Puławska ( Site 1215) | Warsaw, Mazowieckie, 02-777, Poland Recruiting Study Coordinator 793444563
Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200) | Zawadzkie, Opolskie, 47-120, Poland Recruiting Study Coordinator 502545200
Centrum Medyczne Pratia Katowice ( Site 1205) | Katowice, Slaskie, 40-081, Poland Recruiting Study Coordinator +48607931761
Centrum Medyczne Silmedic Sp z o o ( Site 1204) | Katowice, Slaskie, 40-282, Poland Recruiting Study Coordinator +48607040304
Gyncentrum Clinic Sp. z o.o. ( Site 1208) | Katowice, Slaskie, 40-851, Poland Recruiting Study Coordinator +48504039300
RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417) | Belgorod, Belgorodskaya Oblast, 308007, Russian Federation Recruiting Study Coordinator +79803703374
GBUZ Regional Clinical Hospital 3 ( Site 1421) | Chelyabinsk, Chelyabinskaya Oblast, 454021, Russian Federation Completed
City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401) | Kemerovo, Kemerovskaya Oblast, 650000, Russian Federation Recruiting Study Coordinator +73842604019
Moscow City Clinical Hospital Number 13 ( Site 1460) | Moscow, Moskva, 115280, Russian Federation Recruiting Study Coordinator 89037314609
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467) | Moscow, Moskva, 115419, Russian Federation Recruiting Study Coordinator +79104062665
Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439) | Omsk, Omskaya Oblast, 644050, Russian Federation Recruiting Study Coordinator +79139736740
SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409) | Saint Petersburg, Sankt-Peterburg, 194354, Russian Federation Recruiting Study Coordinator +79112904123
GBUZ LO Center of Occupational Pathology ( Site 1447) | Saint Petersburg, Sankt-Peterburg, 195271, Russian Federation Recruiting Study Coordinator +79216476665
SEIHPE Saint Petersburg SMU ( Site 1435) | Saint Petersburg, Sankt-Peterburg, 197022, Russian Federation Recruiting Study Coordinator +79052528564
advisory diagnostic center No.85 ( Site 1455) | Saint Petersburg, Sankt-Peterburg, 198260, Russian Federation Recruiting Study Coordinator +79219007751
Limited Liability Company Kurator ( Site 1425) | St. Petersburg, Sankt-Peterburg, 196240, Russian Federation Recruiting Study Coordinator +79818518150
Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453) | Saratov, Saratovskaya Oblast, 410012, Russian Federation Recruiting Study Coordinator +79272201101
Family Clinic ( Site 1465) | Yekaterinburg, Sverdlovskaya Oblast, 620109, Russian Federation Recruiting Study Coordinator +79122418652
State health Agency Ulyanovsk regional clinical hospital ( Site 1415) | Ulyanovsk, Ul Yanovskaya Oblast, 432063, Russian Federation Recruiting Study Coordinator +79033201711
Voronezh Regional Clinical Hospital #1 ( Site 1441) | Voronezh, Voronezskaja Oblast, 394066, Russian Federation Recruiting Study Coordinator +79601024240
SBCIH of the Yaroslavl region Central city hospital ( Site 1429) | Yaroslavl, Yaroslavskaya Oblast, 150040, Russian Federation Recruiting Study Coordinator +79159752515
Hospital Parc Tauli ( Site 1821) | Sabadell, Barcelona, 08208, Spain Recruiting Study Coordinator +34937231010
Hospital Clinico Universitario de Santiago ( Site 1820) | Santiago de Compostela, La Coruna, 15706, Spain Recruiting Study Coordinator +34981951173
Hospital General Universitario Gregorio Maranon ( Site 1823) | Madrid, Madrid, Comunidad De, 28007, Spain Recruiting Study Coordinator +34915868326
Hospital Ramon y Cajal ( Site 1815) | Madrid, 28034, Spain Recruiting Study Coordinator +34913368864
Hospital Clinico San Carlos ( Site 1822) | Madrid, 28040, Spain Recruiting Study Coordinator +34913303000
Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811) | Kherson, Khersonska Oblast, 73000, Ukraine Recruiting Study Coordinator +380500422845
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802) | Kyiv, Kyivska Oblast, 03038, Ukraine Recruiting Study Coordinator +380975918014
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808) | Kyiv, Kyivska Oblast, 03038, Ukraine Recruiting Study Coordinator +380633912378
SE Road Clinical Hospital 2 of Kyiv station ( Site 2812) | Kyiv, Kyivska Oblast, 03049, Ukraine Recruiting Study Coordinator +380997350900
SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817) | Kyiv, Kyivska Oblast, 03057, Ukraine Recruiting Study Coordinator +380503832333
Odesa regional clinical hospital ( Site 2804) | Odesa, Odeska Oblast, 65025, Ukraine Recruiting Study Coordinator +380503907846
City Polyclinic N20 ( Site 2806) | Odesa, Odeska Oblast, 65114, Ukraine Recruiting Study Coordinator +380674826603
Poltava City Clinical Hospital -1 ( Site 2813) | Poltava, Poltavska Oblast, 36039, Ukraine Recruiting Study Coordinator +380505858953
Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814) | Vinnytsia, Vinnytska Oblast, 21018, Ukraine Recruiting Study Coordinator +380432570572
Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809) | Vinnytsya, Vinnytska Oblast, 21001, Ukraine Recruiting Study Coordinator +380672522328
Volyn Regional Clinical Hospital ( Site 2816) | Lutsk, Volynska Oblast, 43005, Ukraine Recruiting Study Coordinator +380505470790
MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803) | Zaporizhzhia, Zaporizka Oblast, 69096, Ukraine Recruiting Study Coordinator +380507392440
Zhytomyr Central City Hospital No. 1 ( Site 2807) | Zhytomyr, Zhytomyrska Oblast, 10002, Ukraine Completed
Medical Center of LLC Medical Clinic Blahomed ( Site 2815) | Kyiv, 01023, Ukraine Recruiting Study Coordinator +380936306646
MeDiNova Yorkshire Dedicated Research Centre ( Site 2715) | Shipley, Bradford, BD18 3SA, United Kingdom Recruiting Study Coordinator 07495600655
West Walk Surgery ( Site 2700) | Yate, Gloucestershire, BS37 4AX, United Kingdom Recruiting Study Coordinator 01454272200
Medinova South London Research Centre ( Site 2706) | Orpington, Kent, BR5 3QG, United Kingdom Recruiting Study Coordinator +442033013000
Medinova North London Dedicated Research Centre ( Site 2705) | Northwood, London, City Of, HA6 2RN, United Kingdom Recruiting Study Coordinator 01923834230
Kraje lokalizacji

Canada

Colombia

Germany

Guatemala

Korea, Republic of

Peru

Poland

Russian Federation

Spain

Ukraine

United Kingdom

United States

Data weryfikacji

2021-05-01

Odpowiedzialna impreza

Rodzaj: Sponsor

Słowa kluczowe
Ma rozszerzony dostęp Nie
Liczba ramion 2
Grupa Arm

Etykieta: Gefapixant

Rodzaj: Experimental

Opis: Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.

Etykieta: Placebo

Rodzaj: Komparator placebo

Opis: Uczestnicy otrzymają gefapiksant odpowiadający placebo, podawany w postaci tabletki doustnej dwa razy dziennie przez 12 tygodni.

Badanie informacji o projekcie

Przydział: Randomizowane

Model interwencji: Przypisanie równoległe

Podstawowy cel: Leczenie

Maskowanie: Czteroosobowy (uczeń, dostawca opieki, badacz, osoba oceniająca wyniki)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News