A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

NCT03449147 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 7264-030MK-7264-0302017-003559-49
• Study Type: interventional
• Target: 1,317
• Locations: 20 countries
• Sites: 171

Brief Summary

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (3)

• Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline

  24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.

  Baseline, Week 24

• Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to 54 Weeks

• Number of Participants Who Discontinued a Study Drug Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to 52 weeks

Secondary Outcomes (6)

• Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline

  Baseline, Week 24

• Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24

  Baseline, Week 24

• Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24

  Baseline, Week 24

• Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24

  Baseline, Week 24

• Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24

  Baseline, Week 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive a matching placebo tablet BID during the 24-week main study period and the 28-week extension period.

Drug: Placebo

Gefapixant 15 mg BID

EXPERIMENTAL

Participants will receive a gefapixant 15 mg tablet BID and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and the 28-week extension period.

Drug: Placebo; Drug: Gefapixant 15 mg BID

Gefapixant 45 mg BID

EXPERIMENTAL

Participants will receive a gefapixant 45 mg tablet BID and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and during the 28-week extension period.

Drug: Placebo; Drug: Gefapixant 45 mg BID

Interventions

Placebo DRUG

Placebo tablet administered orally BID

Gefapixant 15 mg BID; Gefapixant 45 mg BID; Placebo

Gefapixant 15 mg BID DRUG

Gefapixant 15 mg tablet administered orally BID

Also known as: MK-7264

Gefapixant 15 mg BID

Gefapixant 45 mg BID DRUG

Gefapixant 45 mg tablet administered orally BID

Also known as: MK-7264

Gefapixant 45 mg BID

Eligibility Criteria

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

You may qualify if:

• Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
• Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
• Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
• Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

You may not qualify if:

• Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
• Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
• Has a history of chronic bronchitis
• Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
• Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 at Screening OR an eGFR ≥30 mL/min/1.73 m\^2 and \<50 mL/min/1.73 m\^2 at Screening with unstable renal function
• Has a history of malignancy ≤5 years
• Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
• Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
• Has a known allergy/sensitivity or contraindication to gefapixant
• Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
• Has previously received gefapixant
• Currently participating in or has participated in an interventional clinical study within 30 days of screening

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (171)

Phoenix Medical Group ( Site 0022)

Peoria, Arizona, 85381, United States

Location

Pulmonary Associates, PA ( Site 0063)

Phoenix, Arizona, 85006, United States

Location

Clinical Research Consortium ( Site 0088)

Tempe, Arizona, 85283, United States

Location

Allergy & Asthma Associates of SCV Research Center ( Site 0064)

San Jose, California, 95117, United States

Location

Lenus Research & Medical Group Llc ( Site 0075)

Sweetwater, Florida, 33172, United States

Location

Atlanta Allergy & Asthma Clinic PA ( Site 0029)

Stockbridge, Georgia, 30281, United States

Location

Rush University Medical Center ( Site 0103)

Chicago, Illinois, 60612, United States

Location

Healthcare Research Network LLC ( Site 0093)

Flossmoor, Illinois, 60422, United States

Location

Abraham Research, PLLC ( Site 0107)

Fort Mitchell, Kentucky, 41017, United States

Location

Paul A. Shapero, MD ( Site 0104)

Bangor, Maine, 04401, United States

Location

Bethesda Allergy Asthma and Research Center LLC ( Site 0019)

Bethesda, Maryland, 20814, United States

Location

Respiratory Medicine Research Institute of Michigan, PLC ( Site 0034)

Ypsilanti, Michigan, 48197, United States

Location

Minnesota Lung Center ( Site 0108)

Edina, Minnesota, 55435, United States

Location

Mayo Clinic - Rochester ( Site 0006)

Rochester, Minnesota, 55905, United States

Location

Minnesota Lung Center ( Site 0041)

Woodbury, Minnesota, 55125, United States

Location

The Lung Research Center ( Site 0072)

Chesterfield, Missouri, 63017, United States

Location

University of Missouri ENT & Allergy Center ( Site 0066)

Columbia, Missouri, 65201, United States

Location

CHI Health Creighton University Medical Center ( Site 0024)

Omaha, Nebraska, 68134, United States

Location

Clinical Research Consortium ( Site 0050)

Las Vegas, Nevada, 89109, United States

Location

Atlantic Research Center LLC ( Site 0012)

Ocean City, New Jersey, 07712, United States

Location

Albuquerque Clinical Trials ( Site 0039)

Albuquerque, New Mexico, 87102, United States

Location

Montefiore Medical Center ( Site 0098)

The Bronx, New York, 10461, United States

Location

Wake Research Associates, LLC ( Site 0058)

Raleigh, North Carolina, 27612, United States

Location

Remington-Davis, Inc. ( Site 0082)

Columbus, Ohio, 43215, United States

Location

Clinical Research Institute of Southern Oregon, PC ( Site 0099)

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center ( Site 0026)

Portland, Oregon, 97202, United States

Location

AAPRI Clinical Research Institute ( Site 0001)

Warwick, Rhode Island, 02886, United States

Location

Lowcountry Lung & Critical Care, PA ( Site 0045)

Charleston, South Carolina, 29406, United States

Location

Allergic Disease and Asthma Center ( Site 0043)

Greenville, South Carolina, 29607, United States

Location

Clinical Research of Rock Hill ( Site 0079)

Rock Hill, South Carolina, 29732, United States

Location

Clinical Research Partners, LLC. ( Site 0080)

Richmond, Virginia, 23235, United States

Location

Bellingham Asthma & Allergy ( Site 0076)

Bellingham, Washington, 98225, United States

Location

Marycliff Clinical Research ( Site 0062)

Spokane, Washington, 99202, United States

Location

Multicare Health System ( Site 0018)

Tacoma, Washington, 98405, United States

Location

Australian Clinical Research Network ( Site 0201)

Maroubra, New South Wales, 2035, Australia

Location

Holdsworth House Medical Practice ( Site 0206)

Sydney, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital [Adelaide, Australia] ( Site 0214)

Adelaide, South Australia, 5000, Australia

Location

Trialswest ( Site 0208)

Murdoch, 6150, Australia

Location

Hamilton Medical Research Group ( Site 0510)

Hamilton, Ontario, L8M 1K7, Canada

Location

Recherche GCP Research ( Site 0500)

Montreal, Quebec, H1M 1B1, Canada

Location

Diex Recherche Quebec Inc ( Site 0515)

Québec, Quebec, G1N 4V3, Canada

Location

Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0504)

Québec, Quebec, G1V 4W2, Canada

Location

Clinique de Pneumologie et du Sommeil de Lanaudiere- CPSL ( Site 0516)

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

Q & T Research Sherbrooke Inc. ( Site 0512)

Sherbrooke, Quebec, J1J 2G2, Canada

Location

CIC Mauricie Inc. ( Site 0503)

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Diex Recherche Victoriaville Inc. ( Site 0514)

Victoriaville, Quebec, G6P 6P6, Canada

Location

The First Affiliated Hospital of Fujian Medical University ( Site 5017)

Fuzhou, Fujian, 350005, China

Location

The First Affiliated Hospital of Guangzhou Medical University ( Site 5000)

Guangzhou, Guangdong, 510120, China

Location

Inner Mongolia Autonomous Region Hospital ( Site 5018)

Hohhot, Inner Mongolia, 010017, China

Location

The First Affiliated Hospital of Nanchang University ( Site 5012)

Nanchang, Jiangxi, 330006, China

Location

ShengJing Hospital of China Medical University ( Site 5024)

Shenyang, Liaoning, 110004, China

Location

Shanghai General Hospital ( Site 5010)

Shanghai, Shanghai Municipality, 200080, China

Location

The First Affiliated Hospital of Zhejiang University ( Site 5014)

Hangzhou, Zhejiang, 310003, China

Location

Peking University Third Hospital ( Site 5005)

Beijing, 100191, China

Location

Fundacion Centro de Investigacion Clinica CIC ( Site 0603)

Medellín, Antioquia, 050021, Colombia

Location

Hospital Pablo Tobon Uribe ( Site 0600)

Medellín, Antioquia, 050034, Colombia

Location

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0602)

Medellín, Antioquia, 050036, Colombia

Location

Neumo Investigaciones SAS ( Site 0622)

Bogota, Cundinamarca, 110311, Colombia

Location

Centro Especializado en Enfermedades Pulmonares. ( Site 0620)

Bogota, Cundinamarca, 111831, Colombia

Location

Fundacion Valle del Lili ( Site 0618)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Centro Medico Imbanaco de Cali S.A ( Site 0619)

Cali, Valle del Cauca Department, 760042, Colombia

Location

MedPlus Medicina Prepagada S.A. ( Site 0612)

Bogotá, 110221, Colombia

Location

Instituto Neumologico del Oriente S.A. ( Site 0649)

Bucaramanga, 681004, Colombia

Location

Inst. Prestadora de Servicios de Salud Universidad Antioquia ( Site 0621)

Medellín, 050010, Colombia

Location

MUDr. I. Cierna Peterova s.r.o. ( Site 0707)

Brandýs nad Labem, 250 01, Czechia

Location

MediTrial s.r.o ( Site 0702)

Jindrichuv Hradec III, 377 01, Czechia

Location

Ordinace Pneumologie a diagnostiky Plicnich funkci ( Site 0705)

Karlovy Vary, 360 17, Czechia

Location

PNEUMO-NB s.r.o. ( Site 0710)

Nový Bor, 473 01, Czechia

Location

Nemocnice Tabor a.s. ( Site 0703)

Tábor, 390 03, Czechia

Location

Herlev Hospital ( Site 0803)

Herlev, 2730, Denmark

Location

Bispebjerg Hospital ( Site 0804)

København NV, 2400, Denmark

Location

Aerztezentrum Axel Springer Passage ( Site 1009)

Berlin, 10969, Germany

Location

Atemwegszentrum Neukoeln ( Site 1003)

Berlin, 12043, Germany

Location

Gemeinschaftspraxis Zentrum ( Site 1005)

Frankfurt, 60318, Germany

Location

Pneumologicum im Suedstadtforum ( Site 1004)

Hanover, 30173, Germany

Location

Pneumologenzentrum ( Site 1006)

Leipzig, 04207, Germany

Location

Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 1011)

Neu-Isenburg, 63263, Germany

Location

PneumoConsult Ulm ( Site 1008)

Ulm, 89073, Germany

Location

Clinipharm ( Site 2902)

Guatemala City, 01001, Guatemala

Location

Celan SA ( Site 2900)

Guatemala City, 01010, Guatemala

Location

Consultorio Privado Dr. Jeremias Guerra ( Site 2909)

Guatemala City, 01010, Guatemala

Location

Clinica Medica Especializada en Neumologia ( Site 2901)

Guatemala City, 01011, Guatemala

Location

Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2903)

Guatemala City, 01015, Guatemala

Location

Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)

Balassagyarmat, 2660, Hungary

Location

Synexus Magyarorszag Kft. ( Site 1208)

Budapest, 1036, Hungary

Location

Erzsebet Gondozohaz ( Site 1207)

Gödöllő, 2100, Hungary

Location

Synexus Magyarorszag Kft. ( Site 1210)

Gyula, 5700, Hungary

Location

Lumniczer Sandor Korhaz es Rendelointezet ( Site 1212)

Kapuvár, 9330, Hungary

Location

CRU Hungary KFT ( Site 1205)

Miskolc, 3529, Hungary

Location

Da Vinci Private Clinic - Da Vinci Maganklinika ( Site 1201)

Pécs, 7626, Hungary

Location

Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft ( Site 1203)

Püspökladány, 4150, Hungary

Location

Kaplan Medical Center ( Site 1300)

Rehovot, 7661041, Israel

Location

Azienda Ospedaliero Universitaria Careggi ( Site 1400)

Florence, 50134, Italy

Location

Hospital Sultanah Bahiyah ( Site 1607)

Alor Star, Kedah, 05460, Malaysia

Location

Hospital Taiping ( Site 1600)

Taiping, Perak, 34000, Malaysia

Location

Hospital Pulau Pinang. ( Site 1606)

George Town, Pulau Pinang, 10990, Malaysia

Location

Universiti Teknologi MARA ( Site 1602)

Batu Caves, Selangor, 68100, Malaysia

Location

Institut Perubatan Respiratori ( Site 1605)

Kuala Lumpur, 53000, Malaysia

Location

University Malaya Medical Centre ( Site 1601)

Kuala Lumpur, 59100, Malaysia

Location

Southern Clinical Trials - Waitemata ( Site 0230)

Auckland, 0626, New Zealand

Location

Middlemore Clinical Trials ( Site 0232)

Auckland, 2025, New Zealand

Location

Lakeland Clinical Trials ( Site 0233)

Rotorua, 3010, New Zealand

Location

P3 Research Ltd. ( Site 0228)

Tauranga, 3110, New Zealand

Location

Clinica Ricardo Palma ( Site 1802)

San Isidro, Lima region, 15036, Peru

Location

Hospital Nacional Adolfo Guevara Velasco ( Site 1808)

Cusco, 08000, Peru

Location

Clinica Internacional ( Site 1801)

Lima, 15001, Peru

Location

Asociacion Civil por la Salud ( Site 1805)

Lima, 15046, Peru

Location

Hospital Nacional Cayetano Heredia [Lima, Peru] ( Site 1806)

Lima, 15102, Peru

Location

NZOZ CENTRUM ALERGOLOGII ( Site 1909)

Lublin, Lublin Voivodeship, 20-552, Poland

Location

Centrum Medyczne Pratia Katowice ( Site 1917)

Katowice, Silesian Voivodeship, 40-081, Poland

Location

Centrum Medyczne Silmedic Sp z o o ( Site 1920)

Katowice, Silesian Voivodeship, 40-282, Poland

Location

Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)

Bialystok, 15-044, Poland

Location

KLIMED ( Site 1902)

Bychawa, 23-100, Poland

Location

Gyncentrum Clinic Sp. z o.o. ( Site 1908)

Katowice, 40-851, Poland

Location

Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)

Krakow, 30-033, Poland

Location

Centrum Nowoczesnych Terapii Dobry Lekarz ( Site 1924)

Krakow, 31-011, Poland

Location

Uniwersytecki Szpital Kliniczny im. Norberta Barlickiego nr 1 ( Site 1921)

Lodz, 90-141, Poland

Location

Ostrowieckie Centrum Medyczne ( Site 1915)

Ostrowiec Świętokrzyski, 27-400, Poland

Location

RCMed ( Site 1912)

Sochaczew, 96-500, Poland

Location

Lubelskie Centrum Diagnostyczne ( Site 1913)

Świdnik, 21-040, Poland

Location

Centrum Medyczne Pratia Warszawa ( Site 1911)

Warsaw, 01-868, Poland

Location

Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1923)

Zawadzkie, 47-120, Poland

Location

Iatros International ( Site 2130)

Brandwag, Bloemfontein, 9301, South Africa

Location

Rochester Place Medical Centre ( Site 2129)

Morningside, Gauteng, 2196, South Africa

Location

Jongaie Research ( Site 2131)

Pretoria, Gauteng, 0183, South Africa

Location

Dr N K Gounden Mediclinic ( Site 2134)

Shallcross, KwaZulu-Natal, 4093, South Africa

Location

Drs Lalloo & Ambaram ( Site 2132)

Umhlanga Ridge, KwaZulu-Natal, 4319, South Africa

Location

I Engelbrecht Research ( Site 2128)

Centurion, Tswane, 0157, South Africa

Location

UCT Lung Institute - Bateman ( Site 2126)

Cape Town, Western Cape, 7700, South Africa

Location

Uludag Universitesi Tip Fakultesi ( Site 2621)

Bursa, Gorukle, 16059, Turkey (Türkiye)

Location

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2612)

Adana, 01330, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2602)

Ankara, 06100, Turkey (Türkiye)

Location

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi ( Site 2619)

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi Gogus Hastalıklari ABD ( Site 2610)

Istanbul, 34093, Turkey (Türkiye)

Location

SSK Sureyyapasa Gogus Hastaliklari Hastanesi ( Site 2608)

Istanbul, 34844, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2603)

Izmir, 35040, Turkey (Türkiye)

Location

SBU Dr. Suat Seren Gogus Hast. ve Cer. Egitim ve Arastirma Hast. ( Site 2604)

Izmir, 35110, Turkey (Türkiye)

Location

Celal Bayar University Faculty of Medicine ( Site 2614)

Manisa, 45030, Turkey (Türkiye)

Location

Chernihiv City hospital N2 ( Site 2801)

Chernihiv, 14034, Ukraine

Location

CE Chernivtsi state city clinical hospital 3 ( Site 2806)

Chernivtsi, 58022, Ukraine

Location

Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2812)

Kherson, 73000, Ukraine

Location

Medical Clinic Blagomed LLC ( Site 2807)

Kiev, 01023, Ukraine

Location

Kyiv City Tuberculosis Hospital No. 1 ( Site 2814)

Kyiv, 02091, Ukraine

Location

Medical Association Medbud of the PJSC Kyivmiskbud ( Site 2803)

Kyiv, 03037, Ukraine

Location

SE Road Clinical Hospital 2 of Kyiv station ( Site 2809)

Kyiv, 03049, Ukraine

Location

Institute of Otolaryngology n. a. Prof. A. I. Kolomiychenko ( Site 2833)

Kyiv, 03067, Ukraine

Location

F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2804)

Kyiv, 03680, Ukraine

Location

F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)

Kyiv, 03680, Ukraine

Location

Volyn Regional Clinical Hospital ( Site 2829)

Lutsk, 43005, Ukraine

Location

Poltava City Clinical Hospital 1 ( Site 2808)

Poltava, 36039, Ukraine

Location

Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2819)

Vinnytsia, 21018, Ukraine

Location

MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2811)

Zaporizhzhia, 69065, Ukraine

Location

Zhytomyr Central City Hospital #1 ( Site 2828)

Zhytomyr, 10002, Ukraine

Location

Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 2704)

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Synexus Midlands Clinical Research Centre Ltd ( Site 2719)

Birmingham, Edgbaston, B15 2SQ, United Kingdom

Location

Medinova East London Dedicated Research Centre ( Site 2715)

Romford, Essex, RM1 3PJ, United Kingdom

Location

Medinova South London Dedicated Research Centre ( Site 2714)

Sidcup, Kent, DA14 6LT, United Kingdom

Location

Medinova North London Dedicated Research Centre ( Site 2716)

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Medinova Lakeside Dedicated Research Centre ( Site 2710)

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

Medinova Warwickshire Dedicated Research Centre ( Site 2717)

Kenilworth, Warwickshire, CV8 1JD, United Kingdom

Location

Belfast City Hospital ( Site 2705)

Belfast, BT9 7AB, United Kingdom

Location

Synexus Scotland Clinical Research Centre ( Site 2721)

Glasgow, G20 0SP, United Kingdom

Location

Synexus Merseyside Clinical Research Centre ( Site 2720)

Liverpool, L22 OLG, United Kingdom

Location

Prince Phillip Hospital ( Site 2722)

Llanelli, SA14 8QF, United Kingdom

Location

1Kings College Hospital ( Site 2702)

London, SE5 9RS, United Kingdom

Location

Synexus Manchester Clinical Research Centre ( Site 2718)

Manchester, M15 6SE, United Kingdom

Location

Wythenshawe Hospital ( Site 2700)

Manchester, M23 9LT, United Kingdom

Location

North Tyneside General Hospital ( Site 2707)

North Shields, NE29 8NH, United Kingdom

Location

Rothwell Medical Centre ( Site 2712)

Rothwell, NN14 6JQ, United Kingdom

Location

Taunton and Somerset Hospital ( Site 2723)

Taunton, TA1 5DA, United Kingdom

Location

West Walk Surgery ( Site 2711)

Yate, BS37 4AX, United Kingdom

Location

Related Publications (2)

• Dicpinigaitis PV, Birring SS, Blaiss M, McGarvey LP, Morice AH, Pavord ID, Satia I, Smith JA, La Rosa C, Li Q, Nguyen AM, Schelfhout J, Tzontcheva A, Muccino D. Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough. Ann Allergy Asthma Immunol. 2023 Jan;130(1):60-66. doi: 10.1016/j.anai.2022.05.003. Epub 2022 May 13.

  PMID: 35569802 DERIVED

• McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.

  PMID: 35248186 DERIVED

MeSH Terms

Conditions

Chronic Cough

Interventions

Gefapixant; BID protein, human

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: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

18006726372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants with refractory or unexplained chronic cough will be randomized to 1 of 3 treatment groups: gefapixant 45 mg twice daily (BID), gefapixant 15 mg BID, or placebo.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: March 15, 2018
• Primary Completion: August 20, 2020
• Study Completion: October 30, 2020
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (8); GB (18); GU (5); CZ (5); CO (10); DK (2); PL (14); ZA (7); MY (6); CA (8); TU (9); DE (7); AU (4); UA (15); PE (5); US (34); HU (8); IT (1); NZ (4); IL (1)