Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gefapixant Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks. |
Drug: Gefapixant
Administered twice daily as an oral tablet of 45 mg
Other Names:
|
| Placebo Comparator: Placebo Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. |
Drug: Placebo
Administered twice daily as a placebo oral tablet matching gefapixant
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12 [Baseline, Week 12]
Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score will be calculated.
Secondary Outcome Measures
- Change from baseline in the Cough Severity Visual Analog Scale (VAS) score at Week 12 [Baseline, Week 12]
Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score will be calculated.
- Percentage of participants with one or more adverse events (AEs) [Up to ~Week 14]
An AE is defined as 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. The percentage of participants with one or more AEs will be calculated.
- Percentage of participants who discontinue study drug due to an AE [Up to Week 12]
An AE is defined as 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. The percentage of participants who discontinue study drug due to an AE will be calculated.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Chest radiograph or computerized topography (CT) scan of the thorax performed after the onset of cough symptoms but before the diagnosis of chronic cough require consultation with the Sponsor to determine if acceptable for inclusion in study
-
Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (<14 months after onset of cough symptoms)
-
Has a diagnosis of refractory chronic cough or unexplained chronic cough
-
Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance
Exclusion Criteria:
-
Is a current smoker
-
Has given up smoking within 12 months of screening
-
Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
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Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
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Has a history of chronic bronchitis, defined as cough that produces >1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
-
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
-
Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
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Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
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Has a known allergy to gefapixant or its excipients
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Has donated or lost ≥1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
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Has previously received gefapixant
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Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pulmonary Associates, PA ( Site 0016) | Phoenix | Arizona | United States | 85032 |
| 2 | Center for Clinical Trials, LLC ( Site 0035) | Paramount | California | United States | 90723 |
| 3 | Springfield Clinic, LLP ( Site 0018) | Springfield | Illinois | United States | 62703 |
| 4 | Chesapeake Clinical Research, Inc ( Site 0037) | White Marsh | Maryland | United States | 21162 |
| 5 | Albuquerque Clinical Trials ( Site 0030) | Albuquerque | New Mexico | United States | 87102 |
| 6 | Montefiore Einstein Center ( Site 0022) | Bronx | New York | United States | 10461 |
| 7 | American Health Research ( Site 0047) | Charlotte | North Carolina | United States | 28277 |
| 8 | Clinical Research Institute of Southern Oregon, PC ( Site 0028) | Medford | Oregon | United States | 97504 |
| 9 | Northwest Research Center ( Site 0039) | Portland | Oregon | United States | 97202 |
| 10 | AAPRI Clinical Research Institute ( Site 0051) | Lincoln | Rhode Island | United States | 02865 |
| 11 | Allergic Disease and Asthma Center ( Site 0027) | Greenville | South Carolina | United States | 29607 |
| 12 | Diagnostics Research Group ( Site 0021) | San Antonio | Texas | United States | 78229 |
| 13 | Allergy & Asthma Center ( Site 0001) | Waco | Texas | United States | 76712 |
| 14 | Tidewater Physician Multispecialty Group, PC ( Site 0048) | Williamsburg | Virginia | United States | 23188 |
| 15 | Bellingham Asthma & Allergy ( Site 0011) | Bellingham | Washington | United States | 98225 |
| 16 | Recherche GCP Research ( Site 0802) | Montreal | Quebec | Canada | H1M 1B1 |
| 17 | Diex Recherche Quebec Inc ( Site 0805) | Quebec | Canada | G1N 4V3 | |
| 18 | Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800) | Quebec | Canada | G1V 4W2 | |
| 19 | Fundacion Centro de Investigacion Clinica CIC ( Site 0401) | Medellin | Antioquia | Colombia | 050021 |
| 20 | Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408) | Medellin | Antioquia | Colombia | 050036 |
| 21 | Healthy Medical Center S.A.S ( Site 0404) | Zipaquira | Cundinamarca | Colombia | 250252 |
| 22 | MedPlus Medicina Prepagada S.A. ( Site 0402) | Bogota | Distrito Capital De Bogota | Colombia | 110221 |
| 23 | Centro Especializado en Enfermedades Pulmonares. ( Site 0410) | Bogota | Distrito Capital De Bogota | Colombia | 111831 |
| 24 | Instituto Neumologico del Oriente ( Site 0403) | Floridablanca | Santander | Colombia | 681004 |
| 25 | Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910) | Marburg | Hessen | Germany | 35037 |
| 26 | Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917) | Neu-Isenburg | Hessen | Germany | 63263 |
| 27 | Pneumologicum im Suedstadtforum ( Site 0916) | Hannover | Niedersachsen | Germany | 30173 |
| 28 | Pneumologisches Studienzentrum ( Site 0911) | Berlin | Germany | 10969 | |
| 29 | Celan SA ( Site 0500) | Guatemala | Guatemala | 01010 | |
| 30 | Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504) | Guatemala | Guatemala | 01010 | |
| 31 | Clinica Medica Especializada en Neumologia ( Site 0502) | Guatemala | Guatemala | 01011 | |
| 32 | Private Clinic ( Site 0505) | Guatemala | Guatemala | 01011 | |
| 33 | Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503) | Guatemala | Guatemala | 01015 | |
| 34 | Instituto De Alergias y Enfermedades Respiratorias ( Site 0501) | Guatemala | Guatemala | 01015 | |
| 35 | Wonju Severance Christian Hospital ( Site 1502) | Wonju-si | Kang-won-do | Korea, Republic of | 26426 |
| 36 | Asan Medical Center ( Site 1505) | Songpagu | Seoul | Korea, Republic of | 05505 |
| 37 | Seoul National University Hospital ( Site 1501) | Seoul | Korea, Republic of | 03080 | |
| 38 | Severance Hospital Yonsei University Health System ( Site 1503) | Seoul | Korea, Republic of | 03722 | |
| 39 | Konkuk University Medical Center ( Site 1504) | Seoul | Korea, Republic of | 05030 | |
| 40 | Clinica Ricardo Palma ( Site 0601) | San Isidro | Lima | Peru | 15036 |
| 41 | Asociacion Civil por la Salud ( Site 0602) | Lima | Peru | 15046 | |
| 42 | Hospital Nacional Arzobispo Loayza ( Site 0607) | Lima | Peru | 15082 | |
| 43 | Clinica Belen ( Site 0604) | Piura | Peru | 20001 | |
| 44 | Centrum Medyczne Pratia Bydgoszcz ( Site 1206) | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-796 |
| 45 | NZOZ CENTRUM ALERGOLOGII ( Site 1207) | Lublin | Lubelskie | Poland | 20-552 |
| 46 | Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203) | Krakow | Malopolskie | Poland | 30-033 |
| 47 | RCMed ( Site 1202) | Sochaczew | Mazowieckie | Poland | 96-500 |
| 48 | Centrum Medyczne Puławska ( Site 1215) | Warsaw | Mazowieckie | Poland | 02-777 |
| 49 | Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200) | Zawadzkie | Opolskie | Poland | 47-120 |
| 50 | Centrum Medyczne Pratia Katowice ( Site 1205) | Katowice | Slaskie | Poland | 40-081 |
| 51 | Centrum Medyczne Silmedic Sp z o o ( Site 1204) | Katowice | Slaskie | Poland | 40-282 |
| 52 | Gyncentrum Clinic Sp. z o.o. ( Site 1208) | Katowice | Slaskie | Poland | 40-851 |
| 53 | RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417) | Belgorod | Belgorodskaya Oblast | Russian Federation | 308007 |
| 54 | GBUZ Regional Clinical Hospital 3 ( Site 1421) | Chelyabinsk | Chelyabinskaya Oblast | Russian Federation | 454021 |
| 55 | City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401) | Kemerovo | Kemerovskaya Oblast | Russian Federation | 650000 |
| 56 | Moscow City Clinical Hospital Number 13 ( Site 1460) | Moscow | Moskva | Russian Federation | 115280 |
| 57 | Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467) | Moscow | Moskva | Russian Federation | 115419 |
| 58 | Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439) | Omsk | Omskaya Oblast | Russian Federation | 644050 |
| 59 | SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 194354 |
| 60 | GBUZ LO Center of Occupational Pathology ( Site 1447) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 195271 |
| 61 | SEIHPE Saint Petersburg SMU ( Site 1435) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 197022 |
| 62 | advisory diagnostic center No.85 ( Site 1455) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 198260 |
| 63 | Limited Liability Company Kurator ( Site 1425) | St. Petersburg | Sankt-Peterburg | Russian Federation | 196240 |
| 64 | Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453) | Saratov | Saratovskaya Oblast | Russian Federation | 410012 |
| 65 | Family Clinic ( Site 1465) | Yekaterinburg | Sverdlovskaya Oblast | Russian Federation | 620109 |
| 66 | State health Agency Ulyanovsk regional clinical hospital ( Site 1415) | Ulyanovsk | Ul Yanovskaya Oblast | Russian Federation | 432063 |
| 67 | Voronezh Regional Clinical Hospital #1 ( Site 1441) | Voronezh | Voronezskaja Oblast | Russian Federation | 394066 |
| 68 | SBCIH of the Yaroslavl region Central city hospital ( Site 1429) | Yaroslavl | Yaroslavskaya Oblast | Russian Federation | 150040 |
| 69 | Hospital Parc Tauli ( Site 1821) | Sabadell | Barcelona | Spain | 08208 |
| 70 | Hospital Clinico Universitario de Santiago ( Site 1820) | Santiago de Compostela | La Coruna | Spain | 15706 |
| 71 | Hospital General Universitario Gregorio Maranon ( Site 1823) | Madrid | Madrid, Comunidad De | Spain | 28007 |
| 72 | Hospital Ramon y Cajal ( Site 1815) | Madrid | Spain | 28034 | |
| 73 | Hospital Clinico San Carlos ( Site 1822) | Madrid | Spain | 28040 | |
| 74 | Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811) | Kherson | Khersonska Oblast | Ukraine | 73000 |
| 75 | F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802) | Kyiv | Kyivska Oblast | Ukraine | 03038 |
| 76 | F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808) | Kyiv | Kyivska Oblast | Ukraine | 03038 |
| 77 | SE Road Clinical Hospital 2 of Kyiv station ( Site 2812) | Kyiv | Kyivska Oblast | Ukraine | 03049 |
| 78 | SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817) | Kyiv | Kyivska Oblast | Ukraine | 03057 |
| 79 | Odesa regional clinical hospital ( Site 2804) | Odesa | Odeska Oblast | Ukraine | 65025 |
| 80 | City Polyclinic N20 ( Site 2806) | Odesa | Odeska Oblast | Ukraine | 65114 |
| 81 | Poltava City Clinical Hospital -1 ( Site 2813) | Poltava | Poltavska Oblast | Ukraine | 36039 |
| 82 | Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814) | Vinnytsia | Vinnytska Oblast | Ukraine | 21018 |
| 83 | Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809) | Vinnytsya | Vinnytska Oblast | Ukraine | 21001 |
| 84 | Volyn Regional Clinical Hospital ( Site 2816) | Lutsk | Volynska Oblast | Ukraine | 43005 |
| 85 | MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803) | Zaporizhzhia | Zaporizka Oblast | Ukraine | 69096 |
| 86 | Zhytomyr Central City Hospital No. 1 ( Site 2807) | Zhytomyr | Zhytomyrska Oblast | Ukraine | 10002 |
| 87 | Medical Center of LLC Medical Clinic Blahomed ( Site 2815) | Kyiv | Ukraine | 01023 | |
| 88 | MeDiNova Yorkshire Dedicated Research Centre ( Site 2715) | Shipley | Bradford | United Kingdom | BD18 3SA |
| 89 | West Walk Surgery ( Site 2700) | Yate | Gloucestershire | United Kingdom | BS37 4AX |
| 90 | Medinova South London Research Centre ( Site 2706) | Orpington | Kent | United Kingdom | BR5 3QG |
| 91 | Medinova North London Dedicated Research Centre ( Site 2705) | Northwood | United Kingdom | HA6 2RN |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7264-043
- MK-7264-043
- 2019-002308-42