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

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gefapixant 45 mg twice daily (BID)
Gefapixant 15 mg BID
Placebo
Gefapixant 45 mg BID
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cough

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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 or is currently participating in or has participated in an interventional clinical study

Sites / Locations

  • Phoenix Medical Group ( Site 0022)
  • Pulmonary Associates, PA ( Site 0063)
  • Clinical Research Consortium ( Site 0088)
  • Allergy & Asthma Associates of SCV Research Center ( Site 0064)
  • Lenus Research & Medical Group Llc ( Site 0075)
  • Atlanta Allergy & Asthma Clinic PA ( Site 0029)
  • Rush University Medical Center ( Site 0103)
  • Healthcare Research Network LLC ( Site 0093)
  • Abraham Research, PLLC ( Site 0107)
  • Paul A. Shapero, MD ( Site 0104)
  • Bethesda Allergy Asthma and Research Center LLC ( Site 0019)
  • Respiratory Medicine Research Institute of Michigan, PLC ( Site 0034)
  • Minnesota Lung Center ( Site 0108)
  • Mayo Clinic - Rochester ( Site 0006)
  • Minnesota Lung Center ( Site 0041)
  • The Lung Research Center ( Site 0072)
  • University of Missouri ENT & Allergy Center ( Site 0066)
  • CHI Health Creighton University Medical Center ( Site 0024)
  • Clinical Research Consortium ( Site 0050)
  • Atlantic Research Center LLC ( Site 0012)
  • Albuquerque Clinical Trials ( Site 0039)
  • Montefiore Medical Center ( Site 0098)
  • Wake Research Associates, LLC ( Site 0058)
  • Remington-Davis, Inc. ( Site 0082)
  • Clinical Research Institute of Southern Oregon, PC ( Site 0099)
  • Allergy Associates Research Center ( Site 0026)
  • AAPRI Clinical Research Institute ( Site 0001)
  • Lowcountry Lung & Critical Care, PA ( Site 0045)
  • Allergic Disease and Asthma Center ( Site 0043)
  • Clinical Research of Rock Hill ( Site 0079)
  • Clinical Research Partners, LLC. ( Site 0080)
  • Bellingham Asthma & Allergy ( Site 0076)
  • Marycliff Clinical Research ( Site 0062)
  • Multicare Health System ( Site 0018)
  • Australian Clinical Research Network ( Site 0201)
  • Holdsworth House Medical Practice ( Site 0206)
  • Royal Adelaide Hospital [Adelaide, Australia] ( Site 0214)
  • Trialswest ( Site 0208)
  • Hamilton Medical Research Group ( Site 0510)
  • Recherche GCP Research ( Site 0500)
  • Q & T Research Sherbrooke Inc. ( Site 0512)
  • Clinique de Pneumologie et du Sommeil de Lanaudiere- CPSL ( Site 0516)
  • CIC Mauricie Inc. ( Site 0503)
  • Diex Recherche Victoriaville Inc. ( Site 0514)
  • Diex Recherche Quebec Inc ( Site 0515)
  • Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0504)
  • The First Affiliated Hospital of Fujian Medical University ( Site 5017)
  • The First Affiliated Hospital of Guangzhou Medical University ( Site 5000)
  • Inner Mongolia Autonomous Region Hospital ( Site 5018)
  • The First Affiliated Hospital of Nanchang University ( Site 5012)
  • ShengJing Hospital of China Medical University ( Site 5024)
  • Shanghai General Hospital ( Site 5010)
  • The First Affiliated Hospital of Zhejiang University ( Site 5014)
  • Peking University Third Hospital ( Site 5005)
  • Fundacion Centro de Investigacion Clinica CIC ( Site 0603)
  • Hospital Pablo Tobon Uribe ( Site 0600)
  • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0602)
  • Neumo Investigaciones SAS ( Site 0622)
  • Centro Especializado en Enfermedades Pulmonares. ( Site 0620)
  • Fundacion Valle del Lili ( Site 0618)
  • Centro Medico Imbanaco de Cali S.A ( Site 0619)
  • MedPlus Medicina Prepagada S.A. ( Site 0612)
  • Instituto Neumologico del Oriente S.A. ( Site 0649)
  • Inst. Prestadora de Servicios de Salud Universidad Antioquia ( Site 0621)
  • MUDr. I. Cierna Peterova s.r.o. ( Site 0707)
  • MediTrial s.r.o ( Site 0702)
  • Ordinace Pneumologie a diagnostiky Plicnich funkci ( Site 0705)
  • PNEUMO-NB s.r.o. ( Site 0710)
  • Nemocnice Tabor a.s. ( Site 0703)
  • Herlev Hospital ( Site 0803)
  • Bispebjerg Hospital ( Site 0804)
  • Aerztezentrum Axel Springer Passage ( Site 1009)
  • Atemwegszentrum Neukoeln ( Site 1003)
  • Gemeinschaftspraxis Zentrum ( Site 1005)
  • Pneumologicum im Suedstadtforum ( Site 1004)
  • Pneumologenzentrum ( Site 1006)
  • Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 1011)
  • PneumoConsult Ulm ( Site 1008)
  • Clinipharm ( Site 2902)
  • Celan SA ( Site 2900)
  • Consultorio Privado Dr. Jeremias Guerra ( Site 2909)
  • Clinica Medica Especializada en Neumologia ( Site 2901)
  • Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2903)
  • Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)
  • Synexus Magyarorszag Kft. ( Site 1208)
  • Erzsebet Gondozohaz ( Site 1207)
  • Synexus Magyarorszag Kft. ( Site 1210)
  • Lumniczer Sandor Korhaz es Rendelointezet ( Site 1212)
  • CRU Hungary KFT ( Site 1205)
  • Da Vinci Private Clinic - Da Vinci Maganklinika ( Site 1201)
  • Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft ( Site 1203)
  • Kaplan Medical Center ( Site 1300)
  • Azienda Ospedaliero Universitaria Careggi ( Site 1400)
  • Hospital Sultanah Bahiyah ( Site 1607)
  • Hospital Taiping ( Site 1600)
  • Hospital Pulau Pinang. ( Site 1606)
  • Universiti Teknologi MARA ( Site 1602)
  • Institut Perubatan Respiratori ( Site 1605)
  • University Malaya Medical Centre ( Site 1601)
  • Southern Clinical Trials - Waitemata ( Site 0230)
  • Middlemore Clinical Trials ( Site 0232)
  • Lakeland Clinical Trials ( Site 0233)
  • P3 Research Ltd. ( Site 0228)
  • Clinica Ricardo Palma ( Site 1802)
  • Hospital Nacional Adolfo Guevara Velasco ( Site 1808)
  • Clinica Internacional ( Site 1801)
  • Asociacion Civil por la Salud ( Site 1805)
  • Hospital Nacional Cayetano Heredia [Lima, Peru] ( Site 1806)
  • NZOZ CENTRUM ALERGOLOGII ( Site 1909)
  • Centrum Medyczne Pratia Katowice ( Site 1917)
  • Centrum Medyczne Silmedic Sp z o o ( Site 1920)
  • Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)
  • KLIMED ( Site 1902)
  • Gyncentrum Clinic Sp. z o.o. ( Site 1908)
  • Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)
  • Centrum Nowoczesnych Terapii Dobry Lekarz ( Site 1924)
  • Uniwersytecki Szpital Kliniczny im. Norberta Barlickiego nr 1 ( Site 1921)
  • Ostrowieckie Centrum Medyczne ( Site 1915)
  • RCMed ( Site 1912)
  • Lubelskie Centrum Diagnostyczne ( Site 1913)
  • Centrum Medyczne Pratia Warszawa ( Site 1911)
  • Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1923)
  • Iatros International ( Site 2130)
  • Rochester Place Medical Centre ( Site 2129)
  • Jongaie Research ( Site 2131)
  • Dr N K Gounden Mediclinic ( Site 2134)
  • Drs Lalloo & Ambaram ( Site 2132)
  • I Engelbrecht Research ( Site 2128)
  • UCT Lung Institute - Bateman ( Site 2126)
  • Uludag Universitesi Tip Fakultesi ( Site 2621)
  • Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2612)
  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2602)
  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi ( Site 2619)
  • Istanbul Universitesi Istanbul Tip Fakultesi Gogus Hastalıklari ABD ( Site 2610)
  • SSK Sureyyapasa Gogus Hastaliklari Hastanesi ( Site 2608)
  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2603)
  • SBU Dr. Suat Seren Gogus Hast. ve Cer. Egitim ve Arastirma Hast. ( Site 2604)
  • Celal Bayar University Faculty of Medicine ( Site 2614)
  • Chernihiv City hospital N2 ( Site 2801)
  • CE Chernivtsi state city clinical hospital 3 ( Site 2806)
  • Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2812)
  • Medical Clinic Blagomed LLC ( Site 2807)
  • Kyiv City Tuberculosis Hospital No. 1 ( Site 2814)
  • Medical Association Medbud of the PJSC Kyivmiskbud ( Site 2803)
  • SE Road Clinical Hospital 2 of Kyiv station ( Site 2809)
  • Institute of Otolaryngology n. a. Prof. A. I. Kolomiychenko ( Site 2833)
  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2804)
  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)
  • Volyn Regional Clinical Hospital ( Site 2829)
  • Poltava City Clinical Hospital 1 ( Site 2808)
  • Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2819)
  • MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2811)
  • Zhytomyr Central City Hospital #1 ( Site 2828)
  • Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 2704)
  • Synexus Midlands Clinical Research Centre Ltd ( Site 2719)
  • Medinova East London Dedicated Research Centre ( Site 2715)
  • Medinova South London Dedicated Research Centre ( Site 2714)
  • Medinova North London Dedicated Research Centre ( Site 2716)
  • Medinova Lakeside Dedicated Research Centre ( Site 2710)
  • Medinova Warwickshire Dedicated Research Centre ( Site 2717)
  • Belfast City Hospital ( Site 2705)
  • Synexus Scotland Clinical Research Centre ( Site 2721)
  • Synexus Merseyside Clinical Research Centre ( Site 2720)
  • Prince Phillip Hospital ( Site 2722)
  • 1Kings College Hospital ( Site 2702)
  • Synexus Manchester Clinical Research Centre ( Site 2718)
  • Wythenshawe Hospital ( Site 2700)
  • North Tyneside General Hospital ( Site 2707)
  • Rothwell Medical Centre ( Site 2712)
  • Taunton and Somerset Hospital ( Site 2723)
  • West Walk Surgery ( Site 2711)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Gefapixant 45 mg BID

Gefapixant 15 mg BID

Placebo

Arm Description

Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).

Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).

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

Outcomes

Primary Outcome Measures

Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24
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.
Percentage of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up
Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
Percentage of Participants Who Have a Study Drug Discontinued Due to an AE
Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).

Secondary Outcome Measures

Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.
Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented.
Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24
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 clinically meaningful improvement from baseline is defined as a ≥30% reduction in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≥30% reduction from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
Percentage of Participants With ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥1.3 point reduction from baseline in CSD at Week 24 is reported.
Percentage of Participants With ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥2.7 point reduction from baseline in CSD at Week 24 is reported.
Percentage of Participants With a ≥30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥30mm reduction from baseline in cough severity VAS score at Week 24 is reported.

Full Information

First Posted
August 18, 2020
Last Updated
September 6, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04525885
Brief Title
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2019 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
Detailed Description
This study will have a main 24-week treatment period and a 28-week extension period of treatment. Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefapixant 45 mg BID
Arm Type
Experimental
Arm Description
Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).
Arm Title
Gefapixant 15 mg BID
Arm Type
Experimental
Arm Description
Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period.
Intervention Type
Drug
Intervention Name(s)
Gefapixant 45 mg twice daily (BID)
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant 45 mg tablet to be administered orally BID
Intervention Type
Drug
Intervention Name(s)
Gefapixant 15 mg BID
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant 15 mg tablet to be administered orally BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet administered orally BID
Intervention Type
Drug
Intervention Name(s)
Gefapixant 45 mg BID
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant 45 mg tablet to be administered orally BID
Primary Outcome Measure Information:
Title
Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24
Description
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.
Time Frame
Baseline, Week 24
Title
Percentage of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up
Description
Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
Time Frame
Up to 54 weeks
Title
Percentage of Participants Who Have a Study Drug Discontinued Due to an AE
Description
Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).
Time Frame
Up 52 weeks
Secondary Outcome Measure Information:
Title
Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
Description
Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
Description
The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24
Description
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 clinically meaningful improvement from baseline is defined as a ≥30% reduction in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≥30% reduction from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
Description
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥1.3 point reduction from baseline in CSD at Week 24 is reported.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24
Description
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥2.7 point reduction from baseline in CSD at Week 24 is reported.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With a ≥30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
Description
The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥30mm reduction from baseline in cough severity VAS score at Week 24 is reported.
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 or is currently participating in or has participated in an interventional clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Medical Group ( Site 0022)
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Pulmonary Associates, PA ( Site 0063)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Clinical Research Consortium ( Site 0088)
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Allergy & Asthma Associates of SCV Research Center ( Site 0064)
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Lenus Research & Medical Group Llc ( Site 0075)
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic PA ( Site 0029)
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Rush University Medical Center ( Site 0103)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Healthcare Research Network LLC ( Site 0093)
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Abraham Research, PLLC ( Site 0107)
City
Fort Mitchell
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Paul A. Shapero, MD ( Site 0104)
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Bethesda Allergy Asthma and Research Center LLC ( Site 0019)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Respiratory Medicine Research Institute of Michigan, PLC ( Site 0034)
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minnesota Lung Center ( Site 0108)
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mayo Clinic - Rochester ( Site 0006)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Minnesota Lung Center ( Site 0041)
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
The Lung Research Center ( Site 0072)
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University of Missouri ENT & Allergy Center ( Site 0066)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
CHI Health Creighton University Medical Center ( Site 0024)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research Consortium ( Site 0050)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Atlantic Research Center LLC ( Site 0012)
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Albuquerque Clinical Trials ( Site 0039)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Montefiore Medical Center ( Site 0098)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Wake Research Associates, LLC ( Site 0058)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Remington-Davis, Inc. ( Site 0082)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC ( Site 0099)
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy Associates Research Center ( Site 0026)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
AAPRI Clinical Research Institute ( Site 0001)
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Lowcountry Lung & Critical Care, PA ( Site 0045)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Allergic Disease and Asthma Center ( Site 0043)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Clinical Research of Rock Hill ( Site 0079)
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Clinical Research Partners, LLC. ( Site 0080)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Bellingham Asthma & Allergy ( Site 0076)
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Marycliff Clinical Research ( Site 0062)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Multicare Health System ( Site 0018)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Australian Clinical Research Network ( Site 0201)
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Holdsworth House Medical Practice ( Site 0206)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Adelaide Hospital [Adelaide, Australia] ( Site 0214)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Trialswest ( Site 0208)
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Hamilton Medical Research Group ( Site 0510)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Recherche GCP Research ( Site 0500)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Q & T Research Sherbrooke Inc. ( Site 0512)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
Clinique de Pneumologie et du Sommeil de Lanaudiere- CPSL ( Site 0516)
City
St-Charles-Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
CIC Mauricie Inc. ( Site 0503)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Diex Recherche Victoriaville Inc. ( Site 0514)
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Diex Recherche Quebec Inc ( Site 0515)
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0504)
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
The First Affiliated Hospital of Fujian Medical University ( Site 5017)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University ( Site 5000)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Inner Mongolia Autonomous Region Hospital ( Site 5018)
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University ( Site 5012)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
ShengJing Hospital of China Medical University ( Site 5024)
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Shanghai General Hospital ( Site 5010)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University ( Site 5014)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Peking University Third Hospital ( Site 5005)
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Fundacion Centro de Investigacion Clinica CIC ( Site 0603)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050021
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe ( Site 0600)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0602)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050036
Country
Colombia
Facility Name
Neumo Investigaciones SAS ( Site 0622)
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110311
Country
Colombia
Facility Name
Centro Especializado en Enfermedades Pulmonares. ( Site 0620)
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
111831
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 0618)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 0619)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
MedPlus Medicina Prepagada S.A. ( Site 0612)
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Instituto Neumologico del Oriente S.A. ( Site 0649)
City
Bucaramanga
ZIP/Postal Code
681004
Country
Colombia
Facility Name
Inst. Prestadora de Servicios de Salud Universidad Antioquia ( Site 0621)
City
Medellin
ZIP/Postal Code
050010
Country
Colombia
Facility Name
MUDr. I. Cierna Peterova s.r.o. ( Site 0707)
City
Brandys nad Labem
ZIP/Postal Code
250 01
Country
Czechia
Facility Name
MediTrial s.r.o ( Site 0702)
City
Jindrichuv Hradec III
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
Ordinace Pneumologie a diagnostiky Plicnich funkci ( Site 0705)
City
Karlovy Vary
ZIP/Postal Code
360 17
Country
Czechia
Facility Name
PNEUMO-NB s.r.o. ( Site 0710)
City
Novy Bor
ZIP/Postal Code
473 01
Country
Czechia
Facility Name
Nemocnice Tabor a.s. ( Site 0703)
City
Tabor
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Herlev Hospital ( Site 0803)
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Bispebjerg Hospital ( Site 0804)
City
Kobenhavn NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Aerztezentrum Axel Springer Passage ( Site 1009)
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Atemwegszentrum Neukoeln ( Site 1003)
City
Berlin
ZIP/Postal Code
12043
Country
Germany
Facility Name
Gemeinschaftspraxis Zentrum ( Site 1005)
City
Frankfurt
ZIP/Postal Code
60318
Country
Germany
Facility Name
Pneumologicum im Suedstadtforum ( Site 1004)
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Pneumologenzentrum ( Site 1006)
City
Leipzig
ZIP/Postal Code
04207
Country
Germany
Facility Name
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 1011)
City
Neu-Isenburg
ZIP/Postal Code
63263
Country
Germany
Facility Name
PneumoConsult Ulm ( Site 1008)
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Clinipharm ( Site 2902)
City
Guatemala
ZIP/Postal Code
01001
Country
Guatemala
Facility Name
Celan SA ( Site 2900)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Consultorio Privado Dr. Jeremias Guerra ( Site 2909)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Clinica Medica Especializada en Neumologia ( Site 2901)
City
Guatemala
ZIP/Postal Code
01011
Country
Guatemala
Facility Name
Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2903)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Synexus Magyarorszag Kft. ( Site 1208)
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Erzsebet Gondozohaz ( Site 1207)
City
Godollo
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Synexus Magyarorszag Kft. ( Site 1210)
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Lumniczer Sandor Korhaz es Rendelointezet ( Site 1212)
City
Kapuvar
ZIP/Postal Code
9330
Country
Hungary
Facility Name
CRU Hungary KFT ( Site 1205)
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Da Vinci Private Clinic - Da Vinci Maganklinika ( Site 1201)
City
Pecs
ZIP/Postal Code
7626
Country
Hungary
Facility Name
Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft ( Site 1203)
City
Puspokladany
ZIP/Postal Code
4150
Country
Hungary
Facility Name
Kaplan Medical Center ( Site 1300)
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Careggi ( Site 1400)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Hospital Sultanah Bahiyah ( Site 1607)
City
Alor Star
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Hospital Taiping ( Site 1600)
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Hospital Pulau Pinang. ( Site 1606)
City
George town
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Universiti Teknologi MARA ( Site 1602)
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Institut Perubatan Respiratori ( Site 1605)
City
Kuala Lumpur
ZIP/Postal Code
53000
Country
Malaysia
Facility Name
University Malaya Medical Centre ( Site 1601)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Southern Clinical Trials - Waitemata ( Site 0230)
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Middlemore Clinical Trials ( Site 0232)
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Lakeland Clinical Trials ( Site 0233)
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
P3 Research Ltd. ( Site 0228)
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Clinica Ricardo Palma ( Site 1802)
City
San Isidro
State/Province
Lima
ZIP/Postal Code
15036
Country
Peru
Facility Name
Hospital Nacional Adolfo Guevara Velasco ( Site 1808)
City
Cusco
ZIP/Postal Code
08000
Country
Peru
Facility Name
Clinica Internacional ( Site 1801)
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Asociacion Civil por la Salud ( Site 1805)
City
Lima
ZIP/Postal Code
15046
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia [Lima, Peru] ( Site 1806)
City
Lima
ZIP/Postal Code
15102
Country
Peru
Facility Name
NZOZ CENTRUM ALERGOLOGII ( Site 1909)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-552
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice ( Site 1917)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Centrum Medyczne Silmedic Sp z o o ( Site 1920)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
KLIMED ( Site 1902)
City
Bychawa
ZIP/Postal Code
23-100
Country
Poland
Facility Name
Gyncentrum Clinic Sp. z o.o. ( Site 1908)
City
Katowice
ZIP/Postal Code
40-851
Country
Poland
Facility Name
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz ( Site 1924)
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Norberta Barlickiego nr 1 ( Site 1921)
City
Lodz
ZIP/Postal Code
90-141
Country
Poland
Facility Name
Ostrowieckie Centrum Medyczne ( Site 1915)
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
RCMed ( Site 1912)
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne ( Site 1913)
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa ( Site 1911)
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1923)
City
Zawadzkie
ZIP/Postal Code
47-120
Country
Poland
Facility Name
Iatros International ( Site 2130)
City
Brandwag
State/Province
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Rochester Place Medical Centre ( Site 2129)
City
Morningside
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Jongaie Research ( Site 2131)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Dr N K Gounden Mediclinic ( Site 2134)
City
Shallcross
State/Province
Kwazulu Natal
ZIP/Postal Code
4093
Country
South Africa
Facility Name
Drs Lalloo & Ambaram ( Site 2132)
City
Umhlanga Ridge
State/Province
Kwazulu Natal
ZIP/Postal Code
4319
Country
South Africa
Facility Name
I Engelbrecht Research ( Site 2128)
City
Centurion
State/Province
Tswane
ZIP/Postal Code
0157
Country
South Africa
Facility Name
UCT Lung Institute - Bateman ( Site 2126)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Uludag Universitesi Tip Fakultesi ( Site 2621)
City
Bursa
State/Province
Gorukle
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2612)
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2602)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi ( Site 2619)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi Gogus Hastalıklari ABD ( Site 2610)
City
Istambul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
SSK Sureyyapasa Gogus Hastaliklari Hastanesi ( Site 2608)
City
Istambul
ZIP/Postal Code
34844
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2603)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
SBU Dr. Suat Seren Gogus Hast. ve Cer. Egitim ve Arastirma Hast. ( Site 2604)
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Celal Bayar University Faculty of Medicine ( Site 2614)
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
Facility Name
Chernihiv City hospital N2 ( Site 2801)
City
Chernihiv
ZIP/Postal Code
14034
Country
Ukraine
Facility Name
CE Chernivtsi state city clinical hospital 3 ( Site 2806)
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2812)
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Medical Clinic Blagomed LLC ( Site 2807)
City
Kiev
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Kyiv City Tuberculosis Hospital No. 1 ( Site 2814)
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Medical Association Medbud of the PJSC Kyivmiskbud ( Site 2803)
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
SE Road Clinical Hospital 2 of Kyiv station ( Site 2809)
City
KYiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Institute of Otolaryngology n. a. Prof. A. I. Kolomiychenko ( Site 2833)
City
Kyiv
ZIP/Postal Code
03067
Country
Ukraine
Facility Name
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2804)
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Volyn Regional Clinical Hospital ( Site 2829)
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Facility Name
Poltava City Clinical Hospital 1 ( Site 2808)
City
Poltava
ZIP/Postal Code
36039
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2819)
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2811)
City
Zaporizhzhia
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
Zhytomyr Central City Hospital #1 ( Site 2828)
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 2704)
City
Cottingham
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Centre Ltd ( Site 2719)
City
Birmingham
State/Province
Edgbaston
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Medinova East London Dedicated Research Centre ( Site 2715)
City
Romford
State/Province
Essex
ZIP/Postal Code
RM1 3PJ
Country
United Kingdom
Facility Name
Medinova South London Dedicated Research Centre ( Site 2714)
City
Sidcup
State/Province
Kent
ZIP/Postal Code
DA14 6LT
Country
United Kingdom
Facility Name
Medinova North London Dedicated Research Centre ( Site 2716)
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Medinova Lakeside Dedicated Research Centre ( Site 2710)
City
Corby
State/Province
Northamptonshire
ZIP/Postal Code
NN17 2UR
Country
United Kingdom
Facility Name
Medinova Warwickshire Dedicated Research Centre ( Site 2717)
City
Kenilworth
State/Province
Warwickshire
ZIP/Postal Code
CV8 1JD
Country
United Kingdom
Facility Name
Belfast City Hospital ( Site 2705)
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Centre ( Site 2721)
City
Glasgow
ZIP/Postal Code
G20 0SP
Country
United Kingdom
Facility Name
Synexus Merseyside Clinical Research Centre ( Site 2720)
City
Liverpool
ZIP/Postal Code
L22 OLG
Country
United Kingdom
Facility Name
Prince Phillip Hospital ( Site 2722)
City
Llanelli
ZIP/Postal Code
SA14 8QF
Country
United Kingdom
Facility Name
1Kings College Hospital ( Site 2702)
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Centre ( Site 2718)
City
Manchester
ZIP/Postal Code
M15 6SE
Country
United Kingdom
Facility Name
Wythenshawe Hospital ( Site 2700)
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
North Tyneside General Hospital ( Site 2707)
City
North Shields
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Rothwell Medical Centre ( Site 2712)
City
Rothwell
ZIP/Postal Code
NN14 6JQ
Country
United Kingdom
Facility Name
Taunton and Somerset Hospital ( Site 2723)
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
West Walk Surgery ( Site 2711)
City
Yate
ZIP/Postal Code
BS37 4AX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information

Learn more about this trial

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

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