search
Back to results

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Gefapixant
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
  • Female participants are eligible if not pregnant, not breastfeeding, and either not of childbearing potential, or agree 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
  • Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <60%
  • 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) <30mL/min/1.73 m^2 at Screening OR 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 systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg at Screening
  • 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
  • Had significantly abnormal laboratory tests at Screening

Sites / Locations

  • Research Solutions of Arizona PC ( Site 0036)
  • Medical Research of AZ ( Site 0060)
  • Biosolutions Clinical Research Center ( Site 0070)
  • Center for Clinical Trials, LLC ( Site 0059)
  • Sher Allergy Specialists/Center For Cough ( Site 0078)
  • Well Pharma Medical Research, Corp. ( Site 0093)
  • Florida Pulmonary Research Institute, LLC ( Site 0019)
  • Midwest Allergy Sinus Asthma, SC ( Site 0081)
  • Cotton-O'Neil Clinical Research Center ( Site 0052)
  • BreatheAmerica Inc ( Site 0048)
  • Clinical Research Institute LLC ( Site 0004)
  • The Center for Pharmaceutical Research PC ( Site 0016)
  • American Health Research ( Site 0082)
  • Clinical Research of Gastonia ( Site 0043)
  • Bernstein Clinical Research Center, LLC ( Site 0005)
  • Vital Prospects Clinical Research Institute, PC ( Site 0037)
  • Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)
  • Sirius Clinical Research, LLC ( Site 0102)
  • Pharmaceutical Research & Consulting, Inc. ( Site 0029)
  • Mainland Medical Research Institute ( Site 0003)
  • Diagnostics Research Group ( Site 0035)
  • Allergy & Asthma Center ( Site 0001)
  • Intermountain Clinical Research ( Site 0033)
  • Charlottesville Medical Research Center, LLC ( Site 0006)
  • Pulmonary Associates of Richmond Inc. ( Site 0101)
  • National Clinical Research-Richmond, Inc. ( Site 0073)
  • Lung and Sleep Specialists ( Site 0091)
  • InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)
  • Fundacion CIDEA ( Site 0323)
  • Instituto Ave Pulmo ( Site 0322)
  • Centro Medico Privado de Reumatologia ( Site 0309)
  • Investigaciones en Patologias Respiratorias ( Site 0325)
  • Centro Medico Dra De Salvo ( Site 0310)
  • CEMEDIC - Centro de Especialidades Medicas ( Site 0304)
  • Hospital Privado Universitario de Cordoba ( Site 0313)
  • Fundacion Scherbovsky ( Site 0300)
  • Canadian Phase Onward Inc. ( Site 0509)
  • Recherche GCP Research ( Site 0500)
  • 167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)
  • Dynamik Research ( Site 0505)
  • Q & T Research Sherbrooke Inc. ( Site 0512)
  • CIC Mauricie Inc. ( Site 0503)
  • Diex Recherche Quebec Inc ( Site 0515)
  • MUDr. I. Cierna Peterova s.r.o. ( Site 0707)
  • Plicni ambulance ( Site 0701)
  • Plicni stredisko Teplice s. r. o ( Site 0700)
  • Pneumologie Varnsdorf S.R.O. ( Site 0706)
  • CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)
  • Herlev Hospital ( Site 0803)
  • CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)
  • Hopital Cavale Blanche ( Site 0909)
  • Hopital Nord du Marseille ( Site 0910)
  • Hopital Arnaud de Villeneuve ( Site 0905)
  • CHU Hotel Dieu Nantes ( Site 0906)
  • CHU de Toulouse - Hopital Larrey ( Site 0900)
  • Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)
  • Erzsebet Gondozohaz ( Site 1207)
  • Petz Aladar Megyei Oktato Korhaz ( Site 1206)
  • Synexus Magyarorszag Kft. ( Site 1210)
  • CRU Hungary KFT ( Site 1205)
  • Hillel Yaffe Medical Center ( Site 1303)
  • Carmel Medical Center ( Site 1305)
  • Meir Medical Center ( Site 1301)
  • Rabin Medical Center ( Site 1302)
  • Chaim Sheba Medical Center. ( Site 1304)
  • National Hospital Organization Nagoya Medical Center ( Site 1539)
  • Nagoya City University Hospital ( Site 1528)
  • National Hospital Organization Ehime Medical Center ( Site 1556)
  • Idaimae Minamiyojo Int Clinic ( Site 1521)
  • Terada Clinic Respiratory Medicine & General Practice ( Site 1565)
  • Kinki Central Hospital ( Site 1576)
  • Itami City Hospital ( Site 1580)
  • National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)
  • Ishikawa Prefectural Central Hospital ( Site 1554)
  • Kanazawa University Hospital ( Site 1536)
  • Komatsu Municipal Hospital ( Site 1508)
  • Kamei Internal Medicine and Respiratory Clinic ( Site 1509)
  • Fujisawa City Hospital ( Site 1505)
  • Yokohama City Minato Red Cross Hospital ( Site 1506)
  • Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)
  • Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)
  • Kanagawa Cardiovascular and Respiratory Center ( Site 1503)
  • Matsusaka City Hospital ( Site 1525)
  • Nagaoka Red Cross Hospital ( Site 1507)
  • National Hospital Organization Minami-Okayama Medical Center ( Site 1553)
  • Urasoe General Hospital ( Site 1572)
  • Osaka Habikino Medical Center ( Site 1546)
  • Kawaguchi Respiratory Clinic ( Site 1504)
  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)
  • Tokyo Medical University Hachioji Medical Center ( Site 1569)
  • National Hospital Organization Tokyo National Hospital ( Site 1557)
  • National Hospital Organization Disaster Medical Center ( Site 1558)
  • Shimonoseki City Hospital ( Site 1573)
  • National Hospital Organization Fukuoka Hospital ( Site 1552)
  • Hiroshima Allergy & Respiratory Clinic ( Site 1529)
  • Kyoto University Hospital ( Site 1547)
  • JA Niigatakoseiren Niigata Medical Center ( Site 1522)
  • Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)
  • Juntendo University Hospital ( Site 1578)
  • Tokyo Shinagawa Hospital ( Site 1560)
  • Showa University Hospital ( Site 1531)
  • Center Hospital of the National Center for Global Health and Medicine ( Site 1574)
  • Tokyo Metropolitan Geriatric Hospital ( Site 1577)
  • Wonju Severance Christian Hospital ( Site 2214)
  • Hallym University Sacred Heart Hospital ( Site 2208)
  • Ajou University Hospital ( Site 2211)
  • Incheon St. Mary s Hospital ( Site 2200)
  • Seoul National University Hospital ( Site 2210)
  • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)
  • Severance Hospital ( Site 2204)
  • Konkuk University Medical Center ( Site 2205)
  • Asan Medical Center ( Site 2203)
  • Samsung Medical Center ( Site 2212)
  • The Catholic University of Korea St. Mary s Hospital ( Site 2215)
  • Korea University Guro Hospital ( Site 2213)
  • Clinica Ricardo Palma ( Site 1802)
  • Hospital Nacional Adolfo Guevara Velasco ( Site 1808)
  • Asociacion Civil por la Salud ( Site 1805)
  • Hospital Chancay y Servicios Basicos de Salud ( Site 1810)
  • Prywatny Gabinet Internistyczno ( Site 1928)
  • Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)
  • Centrum Medyczne Pratia Bydgoszcz ( Site 1418)
  • Centrum Medyczne Pratia Czestochowa ( Site 1926)
  • Centrum Medyczne Pratia Gdynia ( Site 1910)
  • Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)
  • USK nr 1 ( Site 1921)
  • Prywatny Gabinet Specjalistyczny ( Site 1927)
  • NZOZCentrum Medyczne Kermed ( Site 1905)
  • Hospital Clinic ( Site 2302)
  • Hospital General Universitario Gregorio Maranon ( Site 2309)
  • Hospital Parc Tauli ( Site 2308)
  • Hospital Clinico Universitario de Santiago ( Site 2303)
  • Changhua Christian Hospital ( Site 2403)
  • Chang Gung Medical Foundation - Keelung Branch ( Site 2404)
  • Far Eastern Memorial Hospital ( Site 2402)
  • Taichung Veterans General Hospital ( Site 2401)
  • National Taiwan University Hospital ( Site 2400)
  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)
  • I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)
  • Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)
  • Kocaeli Universitesi Tip Fakultesi ( Site 2611)
  • Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)
  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)
  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)
  • City Polyclinic N20 ( Site 2822)
  • Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)
  • Royal Preston Hospital ( Site 2709)
  • Medinova Lakeside Dedicated Research Centre ( Site 2710)
  • Belfast City Hospital ( Site 2705)
  • Broomfield Hospital ( Site 2722)
  • Glenfield Hospital ( Site 2701)
  • Royal Brompton Hospital ( Site 2703)
  • Wythenshawe Hospital ( Site 2700)
  • Churchill Hospital ( Site 2706)
  • Rothwell Medical Centre ( Site 2712)
  • MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Gefapixant 15 mg BID

Gefapixant 45 mg BID

Arm Description

Participants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.

Participants receive a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.

Participants receive a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.

Outcomes

Primary Outcome Measures

Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline)
24-hour objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually <24 hours but ≥20 hours). Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough counts to determine geometric mean (GM) 24-hour objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM 24-hour objective coughs per hour divided by the Baseline GM 24-hour objective coughs per hour was reported for all treatment study arms.
Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with at least one AE during either the 52-week treatment period or 2-week telephone follow-up was reported for all treatment study arms.
Number of Participants Who Discontinued Treatment Due to AEs
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention during the 52-week treatment period due to an AE for which the action taken was listed as 'drug withdrawn' was reported for all treatment study arms.

Secondary Outcome Measures

Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)
Awake objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) while the participant is awake divided by the total duration (in hours) for the monitoring period that the participant was awake. Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal ANCOVA model was applied to log-transformed cough counts to determine GM awake objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM awake objective coughs per hour divided by the Baseline GM awake objective coughs per hour was reported for all treatment study arms.
Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12
24-hour coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually <24 hours but ≥20 hours). Assessment based on 24-hour sound recordings using a digital recording device. Percent change in 24-hour coughs per hour = (change from baseline in 24-hour coughs per hour / baseline 24-hour coughs per hour) ×100%. Negative values indicate a decrease in cough rate, while positive values indicate an increase in cough rate. A participant was considered a responder if the percent change from baseline in 24-hour coughs per hour was ≤ -30% (or a ≥30% reduction from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 12 (≥30% reduction from baseline) was reported for all treatment study arms.
Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12
The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -1.3 points (or a ≥1.3 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -1.3 point change from baseline in CSD at Week 12 (or ≥1.3 point reduction from baseline) was reported for all treatment study arms.
Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12
The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -2.7 points (or a ≥2.7 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -2.7 point change from baseline in CSD at Week 12 (or ≥2.7 point reduction from baseline) was reported for all treatment study arms.
Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12
Cough severity was scored using the Cough Severity VAS, a single-item question asking the participant to rate the severity of their cough "today" using a 100 mm VAS (100-point scale) ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was derived as the average of VAS scores collected during the week prior to each visit. Baseline was defined as the average VAS scores collected during the week prior to Day 1 (Day -6 to Day 0). A participant was considered a responder if the change from baseline in mean weekly Cough Severity VAS score was ≤-30 mm (or a ≥30 mm reduction from baseline); participants considered non-responders otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with ≤ -30 mm change from baseline in Cough Severity VAS at Week 12 (≥30 mm reduction from baseline) was reported for all treatment study arms.
Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12
The LCQ assesses the impact of chronic cough on health-related quality of life. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of individual item score within the domain divided by the number of items in the domain. LCQ total score is the sum of the three domain scores and ranges from 3-21; with a higher score corresponding to a better health status. A participant was considered a responder if the change from baseline in LCQ total score was ≥1.3-points (increase from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≥1.3-point change from baseline in LCQ total score at Week 12 was reported for all treatment study arms.

Full Information

First Posted
February 22, 2018
Last Updated
June 15, 2021
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03449134
Brief Title
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)
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 (PN027)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
August 17, 2020 (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 main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.
Detailed Description
The study will include a screening period to determine participant inclusion, and the Baseline visit will include 24 hours of objective measurement of cough. The study will consist of two treatment periods, a main 12-week treatment period and a 40-week extension period (52 weeks total treatment), followed by a 14-day telephone follow-up period. 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, which extends the Estimated Study Completion Date. The Off-treatment Durability Study Period will explore the impact of withdrawing gefapixant in refractory or unexplained chronic cough participants who have been treated for 1 year.

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 during the Treatment Period: Placebo, gefapixant 15 mg twice daily (BID), or gefapixant 45 mg BID. Participants will remain on their assigned treatment throughout the study. A safety follow-up phone call will be conducted at a minimum of 14 days after last dose of study treatment.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
Arm Title
Gefapixant 15 mg BID
Arm Type
Experimental
Arm Description
Participants receive a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.
Arm Title
Gefapixant 45 mg BID
Arm Type
Experimental
Arm Description
Participants receive a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
Intervention Type
Drug
Intervention Name(s)
Gefapixant
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.
Primary Outcome Measure Information:
Title
Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline)
Description
24-hour objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually <24 hours but ≥20 hours). Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough counts to determine geometric mean (GM) 24-hour objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM 24-hour objective coughs per hour divided by the Baseline GM 24-hour objective coughs per hour was reported for all treatment study arms.
Time Frame
Baseline, Week 12
Title
Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up
Description
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with at least one AE during either the 52-week treatment period or 2-week telephone follow-up was reported for all treatment study arms.
Time Frame
Up to approximately 54 weeks
Title
Number of Participants Who Discontinued Treatment Due to AEs
Description
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention during the 52-week treatment period due to an AE for which the action taken was listed as 'drug withdrawn' was reported for all treatment study arms.
Time Frame
Up to approximately 52 weeks
Secondary Outcome Measure Information:
Title
Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)
Description
Awake objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) while the participant is awake divided by the total duration (in hours) for the monitoring period that the participant was awake. Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal ANCOVA model was applied to log-transformed cough counts to determine GM awake objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM awake objective coughs per hour divided by the Baseline GM awake objective coughs per hour was reported for all treatment study arms.
Time Frame
Baseline, Week 12
Title
Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12
Description
24-hour coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually <24 hours but ≥20 hours). Assessment based on 24-hour sound recordings using a digital recording device. Percent change in 24-hour coughs per hour = (change from baseline in 24-hour coughs per hour / baseline 24-hour coughs per hour) ×100%. Negative values indicate a decrease in cough rate, while positive values indicate an increase in cough rate. A participant was considered a responder if the percent change from baseline in 24-hour coughs per hour was ≤ -30% (or a ≥30% reduction from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 12 (≥30% reduction from baseline) was reported for all treatment study arms.
Time Frame
Baseline, Week 12
Title
Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12
Description
The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -1.3 points (or a ≥1.3 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -1.3 point change from baseline in CSD at Week 12 (or ≥1.3 point reduction from baseline) was reported for all treatment study arms.
Time Frame
Baseline, Week 12
Title
Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12
Description
The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -2.7 points (or a ≥2.7 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -2.7 point change from baseline in CSD at Week 12 (or ≥2.7 point reduction from baseline) was reported for all treatment study arms.
Time Frame
Baseline, Week 12
Title
Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12
Description
Cough severity was scored using the Cough Severity VAS, a single-item question asking the participant to rate the severity of their cough "today" using a 100 mm VAS (100-point scale) ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was derived as the average of VAS scores collected during the week prior to each visit. Baseline was defined as the average VAS scores collected during the week prior to Day 1 (Day -6 to Day 0). A participant was considered a responder if the change from baseline in mean weekly Cough Severity VAS score was ≤-30 mm (or a ≥30 mm reduction from baseline); participants considered non-responders otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with ≤ -30 mm change from baseline in Cough Severity VAS at Week 12 (≥30 mm reduction from baseline) was reported for all treatment study arms.
Time Frame
Baseline, Week 12
Title
Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Description
The LCQ assesses the impact of chronic cough on health-related quality of life. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of individual item score within the domain divided by the number of items in the domain. LCQ total score is the sum of the three domain scores and ranges from 3-21; with a higher score corresponding to a better health status. A participant was considered a responder if the change from baseline in LCQ total score was ≥1.3-points (increase from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≥1.3-point change from baseline in LCQ total score at Week 12 was reported for all treatment study arms.
Time Frame
Baseline, Week 12

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 Female participants are eligible if not pregnant, not breastfeeding, and either not of childbearing potential, or agree 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 Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <60% 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) <30mL/min/1.73 m^2 at Screening OR 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 systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg at Screening 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 Had significantly abnormal laboratory tests at Screening
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
Research Solutions of Arizona PC ( Site 0036)
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Medical Research of AZ ( Site 0060)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Biosolutions Clinical Research Center ( Site 0070)
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Center for Clinical Trials, LLC ( Site 0059)
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Sher Allergy Specialists/Center For Cough ( Site 0078)
City
Largo
State/Province
Florida
ZIP/Postal Code
33778
Country
United States
Facility Name
Well Pharma Medical Research, Corp. ( Site 0093)
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC ( Site 0019)
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Midwest Allergy Sinus Asthma, SC ( Site 0081)
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center ( Site 0052)
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
BreatheAmerica Inc ( Site 0048)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Clinical Research Institute LLC ( Site 0004)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
The Center for Pharmaceutical Research PC ( Site 0016)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
American Health Research ( Site 0082)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Clinical Research of Gastonia ( Site 0043)
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC ( Site 0005)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC ( Site 0037)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Sirius Clinical Research, LLC ( Site 0102)
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Pharmaceutical Research & Consulting, Inc. ( Site 0029)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mainland Medical Research Institute ( Site 0003)
City
Dickinson
State/Province
Texas
ZIP/Postal Code
77539
Country
United States
Facility Name
Diagnostics Research Group ( Site 0035)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Allergy & Asthma Center ( Site 0001)
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Intermountain Clinical Research ( Site 0033)
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC ( Site 0006)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Pulmonary Associates of Richmond Inc. ( Site 0101)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
National Clinical Research-Richmond, Inc. ( Site 0073)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Lung and Sleep Specialists ( Site 0091)
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Facility Name
InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Fundacion CIDEA ( Site 0323)
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Instituto Ave Pulmo ( Site 0322)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7602DCK
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia ( Site 0309)
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Investigaciones en Patologias Respiratorias ( Site 0325)
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
Centro Medico Dra De Salvo ( Site 0310)
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
CEMEDIC - Centro de Especialidades Medicas ( Site 0304)
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1407GTN
Country
Argentina
Facility Name
Hospital Privado Universitario de Cordoba ( Site 0313)
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Fundacion Scherbovsky ( Site 0300)
City
Mendoza
ZIP/Postal Code
M5500AXR
Country
Argentina
Facility Name
Canadian Phase Onward Inc. ( Site 0509)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 2C5
Country
Canada
Facility Name
Recherche GCP Research ( Site 0500)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1L5
Country
Canada
Facility Name
Dynamik Research ( Site 0505)
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
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
CIC Mauricie Inc. ( Site 0503)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Diex Recherche Quebec Inc ( Site 0515)
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
MUDr. I. Cierna Peterova s.r.o. ( Site 0707)
City
Brandys nad Labem
ZIP/Postal Code
250 01
Country
Czechia
Facility Name
Plicni ambulance ( Site 0701)
City
Rokycany
ZIP/Postal Code
337 22
Country
Czechia
Facility Name
Plicni stredisko Teplice s. r. o ( Site 0700)
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Pneumologie Varnsdorf S.R.O. ( Site 0706)
City
Varnsdorf
ZIP/Postal Code
407 47
Country
Czechia
Facility Name
CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Herlev Hospital ( Site 0803)
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Hopital Cavale Blanche ( Site 0909)
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Nord du Marseille ( Site 0910)
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Hopital Arnaud de Villeneuve ( Site 0905)
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hotel Dieu Nantes ( Site 0906)
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Toulouse - Hopital Larrey ( Site 0900)
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Erzsebet Gondozohaz ( Site 1207)
City
Godollo
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 1206)
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Synexus Magyarorszag Kft. ( Site 1210)
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
CRU Hungary KFT ( Site 1205)
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Hillel Yaffe Medical Center ( Site 1303)
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Carmel Medical Center ( Site 1305)
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Meir Medical Center ( Site 1301)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 1302)
City
Petah-Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 1304)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 1539)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Nagoya City University Hospital ( Site 1528)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Hospital Organization Ehime Medical Center ( Site 1556)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0281
Country
Japan
Facility Name
Idaimae Minamiyojo Int Clinic ( Site 1521)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Terada Clinic Respiratory Medicine & General Practice ( Site 1565)
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-0849
Country
Japan
Facility Name
Kinki Central Hospital ( Site 1576)
City
Itami
State/Province
Hyogo
ZIP/Postal Code
664-8533
Country
Japan
Facility Name
Itami City Hospital ( Site 1580)
City
Itami
State/Province
Hyogo
ZIP/Postal Code
664-8540
Country
Japan
Facility Name
National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)
City
Naka-gun
State/Province
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital ( Site 1554)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 1536)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Komatsu Municipal Hospital ( Site 1508)
City
Komatsu
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Facility Name
Kamei Internal Medicine and Respiratory Clinic ( Site 1509)
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
761-8073
Country
Japan
Facility Name
Fujisawa City Hospital ( Site 1505)
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
Yokohama City Minato Red Cross Hospital ( Site 1506)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0064
Country
Japan
Facility Name
Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
234-8503
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center ( Site 1503)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Matsusaka City Hospital ( Site 1525)
City
Matsusaka
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Nagaoka Red Cross Hospital ( Site 1507)
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
National Hospital Organization Minami-Okayama Medical Center ( Site 1553)
City
Tsukubo-gun
State/Province
Okayama
ZIP/Postal Code
701-0304
Country
Japan
Facility Name
Urasoe General Hospital ( Site 1572)
City
Urasoe
State/Province
Okinawa
ZIP/Postal Code
901-2132
Country
Japan
Facility Name
Osaka Habikino Medical Center ( Site 1546)
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Kawaguchi Respiratory Clinic ( Site 1504)
City
Higashiosaka
State/Province
Osaka
ZIP/Postal Code
577-0843
Country
Japan
Facility Name
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center ( Site 1569)
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
National Hospital Organization Tokyo National Hospital ( Site 1557)
City
Kiyose
State/Province
Tokyo
ZIP/Postal Code
204-8585
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center ( Site 1558)
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Shimonoseki City Hospital ( Site 1573)
City
Shimonoseki
State/Province
Yamaguchi
ZIP/Postal Code
750-8520
Country
Japan
Facility Name
National Hospital Organization Fukuoka Hospital ( Site 1552)
City
Fukuoka
ZIP/Postal Code
811-1394
Country
Japan
Facility Name
Hiroshima Allergy & Respiratory Clinic ( Site 1529)
City
Hiroshima
ZIP/Postal Code
732-0052
Country
Japan
Facility Name
Kyoto University Hospital ( Site 1547)
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
JA Niigatakoseiren Niigata Medical Center ( Site 1522)
City
Niigata
ZIP/Postal Code
950-2022
Country
Japan
Facility Name
Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Juntendo University Hospital ( Site 1578)
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Shinagawa Hospital ( Site 1560)
City
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
Showa University Hospital ( Site 1531)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine ( Site 1574)
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Tokyo Metropolitan Geriatric Hospital ( Site 1577)
City
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Facility Name
Wonju Severance Christian Hospital ( Site 2214)
City
Wonju-si
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital ( Site 2208)
City
Anyang si
State/Province
Gyeonggi Do
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Ajou University Hospital ( Site 2211)
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Incheon St. Mary s Hospital ( Site 2200)
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 2210)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Severance Hospital ( Site 2204)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center ( Site 2205)
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2203)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2212)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Mary s Hospital ( Site 2215)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 2213)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
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
08006
Country
Peru
Facility Name
Asociacion Civil por la Salud ( Site 1805)
City
Lima
ZIP/Postal Code
15046
Country
Peru
Facility Name
Hospital Chancay y Servicios Basicos de Salud ( Site 1810)
City
Lima
ZIP/Postal Code
15131
Country
Peru
Facility Name
Prywatny Gabinet Internistyczno ( Site 1928)
City
Bialystok
ZIP/Postal Code
15-010
Country
Poland
Facility Name
Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Centrum Medyczne Pratia Bydgoszcz ( Site 1418)
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Centrum Medyczne Pratia Czestochowa ( Site 1926)
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia ( Site 1910)
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
USK nr 1 ( Site 1921)
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Prywatny Gabinet Specjalistyczny ( Site 1927)
City
Lodz
ZIP/Postal Code
91-849
Country
Poland
Facility Name
NZOZCentrum Medyczne Kermed ( Site 1905)
City
Znin
ZIP/Postal Code
88-400
Country
Poland
Facility Name
Hospital Clinic ( Site 2302)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 2309)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Parc Tauli ( Site 2308)
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago ( Site 2303)
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Changhua Christian Hospital ( Site 2403)
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Keelung Branch ( Site 2404)
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital ( Site 2402)
City
New Taipei City
ZIP/Postal Code
22056
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 2401)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 2400)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)
City
Fatih
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)
City
Istanbul
ZIP/Postal Code
34020
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi ( Site 2611)
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)
City
Rize
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
City Polyclinic N20 ( Site 2822)
City
Odesa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)
City
Vinnytsya
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Royal Preston Hospital ( Site 2709)
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
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
Belfast City Hospital ( Site 2705)
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Broomfield Hospital ( Site 2722)
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Glenfield Hospital ( Site 2701)
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Royal Brompton Hospital ( Site 2703)
City
London
ZIP/Postal Code
SW3 6JY
Country
United Kingdom
Facility Name
Wythenshawe Hospital ( Site 2700)
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Churchill Hospital ( Site 2706)
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Rothwell Medical Centre ( Site 2712)
City
Rothwell
ZIP/Postal Code
NN14 6JQ
Country
United Kingdom
Facility Name
MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)
City
Shipley
ZIP/Postal Code
BD18 3SA
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
Citations:
PubMed Identifier
35569802
Citation
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.
Results Reference
derived
PubMed Identifier
35248186
Citation
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.
Results Reference
derived

Learn more about this trial

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

We'll reach out to this number within 24 hrs