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

June 15, 2021 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
732

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Centro Medico Dra De Salvo ( Site 0310)
      • Ciudad Autonoma de Buenos Aires, Argentina, C1407GTN
        • CEMEDIC - Centro de Especialidades Medicas ( Site 0304)
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Universitario de Cordoba ( Site 0313)
      • Mendoza, Argentina, M5500AXR
        • Fundacion Scherbovsky ( Site 0300)
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1425BEN
        • InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Fundacion CIDEA ( Site 0323)
      • Mar del Plata, Buenos Aires, Argentina, B7602DCK
        • Instituto Ave Pulmo ( Site 0322)
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia ( Site 0309)
      • San Miguel de Tucuman, Tucuman, Argentina, T4000IAR
        • Investigaciones en Patologias Respiratorias ( Site 0325)
  • Canada
      • Quebec, Canada, G1N 4V3
        • Diex Recherche Quebec Inc ( Site 0515)
    • Ontario
      • Toronto, Ontario, Canada, M3J 2C5
        • Canadian Phase Onward Inc. ( Site 0509)
    • Quebec
      • Montreal, Quebec, Canada, H1M 1B1
        • Recherche GCP Research ( Site 0500)
      • Montreal, Quebec, Canada, H3G 1L5
        • 167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Dynamik Research ( Site 0505)
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Q & T Research Sherbrooke Inc. ( Site 0512)
      • Trois-Rivieres, Quebec, Canada, G8T 7A1
        • CIC Mauricie Inc. ( Site 0503)
  • Czechia
      • Brandys nad Labem, Czechia, 250 01
        • MUDr. I. Cierna Peterova s.r.o. ( Site 0707)
      • Rokycany, Czechia, 337 22
        • Plicni ambulance ( Site 0701)
      • Teplice, Czechia, 415 01
        • Plicni stredisko Teplice s. r. o ( Site 0700)
      • Varnsdorf, Czechia, 407 47
        • Pneumologie Varnsdorf S.R.O. ( Site 0706)
  • Denmark
      • Aalborg, Denmark, 9000
        • CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)
      • Herlev, Denmark, 2730
        • Herlev Hospital ( Site 0803)
      • Vejle, Denmark, 7100
        • CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)
  • France
      • Brest, France, 29609
        • Hopital Cavale Blanche ( Site 0909)
      • Marseille, France, 13015
        • Hopital Nord du Marseille ( Site 0910)
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve ( Site 0905)
      • Nantes, France, 44093
        • CHU Hotel Dieu Nantes ( Site 0906)
      • Toulouse, France, 31100
        • CHU de Toulouse - Hopital Larrey ( Site 0900)
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)
      • Godollo, Hungary, 2100
        • Erzsebet Gondozohaz ( Site 1207)
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz ( Site 1206)
      • Gyula, Hungary, 5700
        • Synexus Magyarorszag Kft. ( Site 1210)
      • Miskolc, Hungary, 3529
        • CRU Hungary KFT ( Site 1205)
  • Israel
      • Hadera, Israel, 3810101
        • Hillel Yaffe Medical Center ( Site 1303)
      • Haifa, Israel, 3436212
        • Carmel Medical Center ( Site 1305)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center ( Site 1301)
      • Petah-Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 1302)
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center. ( Site 1304)
  • Japan
      • Fukuoka, Japan, 811-1394
        • National Hospital Organization Fukuoka Hospital ( Site 1552)
      • Hiroshima, Japan, 732-0052
        • Hiroshima Allergy & Respiratory Clinic ( Site 1529)
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital ( Site 1547)
      • Niigata, Japan, 950-2022
        • JA Niigatakoseiren Niigata Medical Center ( Site 1522)
      • Shizuoka, Japan, 420-8527
        • Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital ( Site 1578)
      • Tokyo, Japan, 140-8522
        • Tokyo Shinagawa Hospital ( Site 1560)
      • Tokyo, Japan, 142-8666
        • Showa University Hospital ( Site 1531)
      • Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine ( Site 1574)
      • Tokyo, Japan, 173-0015
        • Tokyo Metropolitan Geriatric Hospital ( Site 1577)
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 1539)
      • Nagoya, Aichi, Japan, 467-8602
        • Nagoya City University Hospital ( Site 1528)
    • Ehime
      • Toon, Ehime, Japan, 791-0281
        • National Hospital Organization Ehime Medical Center ( Site 1556)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 064-0804
        • Idaimae Minamiyojo Int Clinic ( Site 1521)
    • Hyogo
      • Himeji, Hyogo, Japan, 670-0849
        • Terada Clinic Respiratory Medicine & General Practice ( Site 1565)
      • Itami, Hyogo, Japan, 664-8533
        • Kinki Central Hospital ( Site 1576)
      • Itami, Hyogo, Japan, 664-8540
        • Itami City Hospital ( Site 1580)
    • Ibaraki
      • Naka-gun, Ibaraki, Japan, 319-1113
        • National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital ( Site 1554)
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital ( Site 1536)
      • Komatsu, Ishikawa, Japan, 923-8560
        • Komatsu Municipal Hospital ( Site 1508)
    • Kagawa
      • Takamatsu, Kagawa, Japan, 761-8073
        • Kamei Internal Medicine and Respiratory Clinic ( Site 1509)
    • Kanagawa
      • Fujisawa, Kanagawa, Japan, 251-8550
        • Fujisawa City Hospital ( Site 1505)
      • Yokohama, Kanagawa, Japan, 231-8682
        • Yokohama City Minato Red Cross Hospital ( Site 1506)
      • Yokohama, Kanagawa, Japan, 232-0064
        • Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)
      • Yokohama, Kanagawa, Japan, 234-8503
        • Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)
      • Yokohama, Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center ( Site 1503)
    • Mie
      • Matsusaka, Mie, Japan, 515-8544
        • Matsusaka City Hospital ( Site 1525)
    • Niigata
      • Nagaoka, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital ( Site 1507)
    • Okayama
      • Tsukubo-gun, Okayama, Japan, 701-0304
        • National Hospital Organization Minami-Okayama Medical Center ( Site 1553)
    • Okinawa
      • Urasoe, Okinawa, Japan, 901-2132
        • Urasoe General Hospital ( Site 1572)
    • Osaka
      • Habikino, Osaka, Japan, 583-8588
        • Osaka Habikino Medical Center ( Site 1546)
      • Higashiosaka, Osaka, Japan, 577-0843
        • Kawaguchi Respiratory Clinic ( Site 1504)
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)
    • Tokyo
      • Hachioji, Tokyo, Japan, 193-0998
        • Tokyo Medical University Hachioji Medical Center ( Site 1569)
      • Kiyose, Tokyo, Japan, 204-8585
        • National Hospital Organization Tokyo National Hospital ( Site 1557)
      • Tachikawa, Tokyo, Japan, 190-0014
        • National Hospital Organization Disaster Medical Center ( Site 1558)
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 750-8520
        • Shimonoseki City Hospital ( Site 1573)
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21431
        • Incheon St. Mary s Hospital ( Site 2200)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 2210)
      • Seoul, Korea, Republic of, 03312
        • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital ( Site 2204)
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center ( Site 2205)
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 2203)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 2212)
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea St. Mary s Hospital ( Site 2215)
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital ( Site 2213)
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital ( Site 2214)
    • Gyeonggi Do
      • Anyang si, Gyeonggi Do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital ( Site 2208)
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital ( Site 2211)
  • Peru
      • Cusco, Peru, 08006
        • Hospital Nacional Adolfo Guevara Velasco ( Site 1808)
      • Lima, Peru, 15046
        • Asociacion Civil por la Salud ( Site 1805)
      • Lima, Peru, 15131
        • Hospital Chancay y Servicios Basicos de Salud ( Site 1810)
    • Lima
      • San Isidro, Lima, Peru, 15036
        • Clinica Ricardo Palma ( Site 1802)
  • Poland
      • Bialystok, Poland, 15-010
        • Prywatny Gabinet Internistyczno ( Site 1928)
      • Białystok, Poland, 15-044
        • Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)
      • Bydgoszcz, Poland, 85-796
        • Centrum Medyczne Pratia Bydgoszcz ( Site 1418)
      • Czestochowa, Poland, 42-200
        • Centrum Medyczne Pratia Czestochowa ( Site 1926)
      • Gdynia, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia ( Site 1910)
      • Krakow, Poland, 30-033
        • Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)
      • Lodz, Poland, 90-153
        • USK nr 1 ( Site 1921)
      • Lodz, Poland, 91-849
        • Prywatny Gabinet Specjalistyczny ( Site 1927)
      • Znin, Poland, 88-400
        • NZOZCentrum Medyczne Kermed ( Site 1905)
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic ( Site 2302)
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon ( Site 2309)
      • Sabadell, Spain, 08208
        • Hospital Parc Tauli ( Site 2308)
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago ( Site 2303)
  • Taiwan
      • Changhua, Taiwan, 50006
        • Changhua Christian Hospital ( Site 2403)
      • Keelung, Taiwan, 20401
        • Chang Gung Medical Foundation - Keelung Branch ( Site 2404)
      • New Taipei City, Taiwan, 22056
        • Far Eastern Memorial Hospital ( Site 2402)
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital ( Site 2401)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 2400)
  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)
      • Fatih, Turkey, 34098
        • I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)
      • Istanbul, Turkey, 34020
        • Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)
      • Kocaeli, Turkey, 41380
        • Kocaeli Universitesi Tip Fakultesi ( Site 2611)
      • Rize, Turkey, 55200
        • Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)
      • Samsun, Turkey, 55139
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)
  • Ukraine
      • Kyiv, Ukraine, 03680
        • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)
      • Odesa, Ukraine, 65114
        • City Polyclinic N20 ( Site 2822)
      • Vinnytsya, Ukraine, 21001
        • Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital ( Site 2705)
      • Chelmsford, United Kingdom, CM1 7ET
        • Broomfield Hospital ( Site 2722)
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital ( Site 2701)
      • London, United Kingdom, SW3 6JY
        • Royal Brompton Hospital ( Site 2703)
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital ( Site 2700)
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital ( Site 2706)
      • Rothwell, United Kingdom, NN14 6JQ
        • Rothwell Medical Centre ( Site 2712)
      • Shipley, United Kingdom, BD18 3SA
        • MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Royal Preston Hospital ( Site 2709)
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UR
        • Medinova Lakeside Dedicated Research Centre ( Site 2710)
  • United States
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona PC ( Site 0036)
      • Scottsdale, Arizona, United States, 85251
        • Medical Research of AZ ( Site 0060)
    • California
      • La Mesa, California, United States, 91942
        • Biosolutions Clinical Research Center ( Site 0070)
      • Paramount, California, United States, 90723
        • Center for Clinical Trials, LLC ( Site 0059)
    • Florida
      • Largo, Florida, United States, 33778
        • Sher Allergy Specialists/Center For Cough ( Site 0078)
      • Miami, Florida, United States, 33143
        • Well Pharma Medical Research, Corp. ( Site 0093)
      • Winter Park, Florida, United States, 32789
        • Florida Pulmonary Research Institute, LLC ( Site 0019)
    • Illinois
      • Normal, Illinois, United States, 61761
        • Midwest Allergy Sinus Asthma, SC ( Site 0081)
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center ( Site 0052)
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • BreatheAmerica Inc ( Site 0048)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute LLC ( Site 0004)
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research PC ( Site 0016)
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • American Health Research ( Site 0082)
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research of Gastonia ( Site 0043)
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center, LLC ( Site 0005)
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute, PC ( Site 0037)
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)
    • Texas
      • Austin, Texas, United States, 78759
        • Sirius Clinical Research, LLC ( Site 0102)
      • Dallas, Texas, United States, 75231
        • Pharmaceutical Research & Consulting, Inc. ( Site 0029)
      • Dickinson, Texas, United States, 77539
        • Mainland Medical Research Institute ( Site 0003)
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group ( Site 0035)
      • Waco, Texas, United States, 76712
        • Allergy & Asthma Center ( Site 0001)
    • Utah
      • Draper, Utah, United States, 84020
        • Intermountain Clinical Research ( Site 0033)
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center, LLC ( Site 0006)
      • Richmond, Virginia, United States, 23225
        • Pulmonary Associates of Richmond Inc. ( Site 0101)
      • Richmond, Virginia, United States, 23294
        • National Clinical Research-Richmond, Inc. ( Site 0073)
      • Williamsburg, Virginia, United States, 23188
        • Lung and Sleep Specialists ( Site 0091)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
Drug: Placebo
Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
Experimental: Gefapixant 15 mg BID
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.
Drug: Placebo
Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
Drug: Gefapixant
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.
Other Names:
  • MK-7264
Experimental: Gefapixant 45 mg BID
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.
Drug: Placebo
Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
Drug: Gefapixant
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.
Other Names:
  • MK-7264

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline)
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up
Time Frame: Up to approximately 54 weeks
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.
Up to approximately 54 weeks
Number of Participants Who Discontinued Treatment Due to AEs
Time Frame: Up to approximately 52 weeks
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.
Up to approximately 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12
Time Frame: Baseline, 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.
Baseline, Week 12
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
Time Frame: Baseline, 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.
Baseline, Week 12
Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12
Time Frame: Baseline, 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.
Baseline, Week 12
Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12
Time Frame: Baseline, 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.
Baseline, Week 12
Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Time Frame: Baseline, 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.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7264-027
  • MK-7264-027 (Other Identifier: Merck Protocol Number)
  • 2017-000537-31 (EudraCT Number)
  • 184098 (Registry Identifier: JAPAN-CTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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

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