A Study of Gefapixant (MK-7264) in Adult Participants Wit... | NCT03449134 | Trialant
NCT03449134
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jun 16, 2021Actual
Enrollment
732Actual
Phase
Phase 3
Conditions
Chronic Cough
Interventions
Placebo
Gefapixant
Countries
United States
Argentina
Canada
Czechia
Denmark
France
Hungary
Israel
Japan
Peru
Poland
South Korea
Spain
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03449134
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7264-027
Secondary IDs
ID
Type
Description
Link
MK-7264-027
Other Identifier
Merck Protocol Number
2017-000537-31
EudraCT Number
184098
Registry Identifier
JAPAN-CTI
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)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jun 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Mar 14, 2018Actual
Primary Completion Date
Jun 5, 2020Actual
Completion Date
Aug 17, 2020Actual
First Submitted Date
Feb 22, 2018
First Submission Date that Met QC Criteria
Feb 22, 2018
First Posted Date
Feb 28, 2018Actual
Results Waived
Not provided
Results First Submitted Date
May 7, 2021
Results First Submitted that Met QC Criteria
Jun 15, 2021
Results First Posted Date
Jun 16, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 15, 2021
Last Update Posted Date
Jun 16, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Chronic Cough
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
732Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
Drug: Placebo
Gefapixant 15 mg BID
Experimental
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
Drug: Gefapixant
Gefapixant 45 mg BID
Experimental
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
Drug: Gefapixant
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
Gefapixant 15 mg BID
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline, Week 12
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.
Up to approximately 54 weeks
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.
Up to approximately 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
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
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.
Of 732 participants randomized to the 52-week treatment period, 730 participants received at least 1 dose of study intervention. After the main study, 41 participants continued in an optional Off-Treatment observational study period (no treatment).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
FG001
Gefapixant 15 mg BID
Participants received 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.
Periods
Title
Milestones
Reasons Not Completed
52-Week Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Apr 26, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Gefapixant 45 mg BID
Placebo
Gefapixant
Drug
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.
Gefapixant 15 mg BID
Gefapixant 45 mg BID
MK-7264
Baseline, Week 12
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.
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
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
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
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
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
Scottsdale
Arizona
85251
United States
Biosolutions Clinical Research Center ( Site 0070)
La Mesa
California
91942
United States
Center for Clinical Trials, LLC ( Site 0059)
Paramount
California
90723
United States
Sher Allergy Specialists/Center For Cough ( Site 0078)
Largo
Florida
33778
United States
Well Pharma Medical Research, Corp. ( Site 0093)
Miami
Florida
33143
United States
Florida Pulmonary Research Institute, LLC ( Site 0019)
Winter Park
Florida
32789
United States
Midwest Allergy Sinus Asthma, SC ( Site 0081)
Normal
Illinois
61761
United States
Cotton-O'Neil Clinical Research Center ( Site 0052)
Topeka
Kansas
66606
United States
BreatheAmerica Inc ( Site 0048)
Shreveport
Louisiana
71106
United States
Clinical Research Institute LLC ( Site 0004)
Minneapolis
Minnesota
55402
United States
The Center for Pharmaceutical Research PC ( Site 0016)
Kansas City
Missouri
64114
United States
American Health Research ( Site 0082)
Charlotte
North Carolina
28207
United States
Clinical Research of Gastonia ( Site 0043)
Gastonia
North Carolina
28054
United States
Bernstein Clinical Research Center, LLC ( Site 0005)
Cincinnati
Ohio
45231
United States
Vital Prospects Clinical Research Institute, PC ( Site 0037)
Tulsa
Oklahoma
74136
United States
Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)
East Providence
Rhode Island
02914
United States
Sirius Clinical Research, LLC ( Site 0102)
Austin
Texas
78759
United States
Pharmaceutical Research & Consulting, Inc. ( Site 0029)
Dallas
Texas
75231
United States
Mainland Medical Research Institute ( Site 0003)
Dickinson
Texas
77539
United States
Diagnostics Research Group ( Site 0035)
San Antonio
Texas
78229
United States
Allergy & Asthma Center ( Site 0001)
Waco
Texas
76712
United States
Intermountain Clinical Research ( Site 0033)
Draper
Utah
84020
United States
Charlottesville Medical Research Center, LLC ( Site 0006)
Charlottesville
Virginia
22911
United States
Pulmonary Associates of Richmond Inc. ( Site 0101)
Richmond
Virginia
23225
United States
National Clinical Research-Richmond, Inc. ( Site 0073)
Richmond
Virginia
23294
United States
Lung and Sleep Specialists ( Site 0091)
Williamsburg
Virginia
23188
United States
InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)
Caba
Buenos Aires
C1425BEN
Argentina
Fundacion CIDEA ( Site 0323)
Ciudad de Buenos Aires
Buenos Aires
C1121ABE
Argentina
Instituto Ave Pulmo ( Site 0322)
Mar del Plata
Buenos Aires
B7602DCK
Argentina
Centro Medico Privado de Reumatologia ( Site 0309)
San Miguel de Tucumán
Tucumán Province
T4000AXL
Argentina
Investigaciones en Patologias Respiratorias ( Site 0325)
San Miguel de Tucumán
Tucumán Province
T4000IAR
Argentina
CEMEDIC - Centro de Especialidades Medicas ( Site 0304)
Buenos Aires
C1407GTN
Argentina
Centro Medico Dra De Salvo ( Site 0310)
Buenos Aires
C1426ABP
Argentina
Hospital Privado Universitario de Cordoba ( Site 0313)
Córdoba
X5016KEH
Argentina
Fundacion Scherbovsky ( Site 0300)
Mendoza
M5500AXR
Argentina
Canadian Phase Onward Inc. ( Site 0509)
Toronto
Ontario
M3J 2C5
Canada
Recherche GCP Research ( Site 0500)
Montreal
Quebec
H1M 1B1
Canada
167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)
Montreal
Quebec
H3G 1L5
Canada
Dynamik Research ( Site 0505)
Pointe-Claire
Quebec
H9R 3J1
Canada
Diex Recherche Quebec Inc ( Site 0515)
Québec
Quebec
G1N 4V3
Canada
Q & T Research Sherbrooke Inc. ( Site 0512)
Sherbrooke
Quebec
J1J 2G2
Canada
CIC Mauricie Inc. ( Site 0503)
Trois-Rivières
Quebec
G8T 7A1
Canada
MUDr. I. Cierna Peterova s.r.o. ( Site 0707)
Brandýs nad Labem
250 01
Czechia
Plicni ambulance ( Site 0701)
Rokycany
337 22
Czechia
Plicni stredisko Teplice s. r. o ( Site 0700)
Teplice
415 01
Czechia
Pneumologie Varnsdorf S.R.O. ( Site 0706)
Varnsdorf
407 47
Czechia
CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)
Aalborg
9000
Denmark
Herlev Hospital ( Site 0803)
Herlev
2730
Denmark
CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)
Vejle
7100
Denmark
Hopital Cavale Blanche ( Site 0909)
Brest
29609
France
Hopital Nord du Marseille ( Site 0910)
Marseille
13015
France
Hopital Arnaud de Villeneuve ( Site 0905)
Montpellier
34295
France
CHU Hotel Dieu Nantes ( Site 0906)
Nantes
44093
France
CHU de Toulouse - Hopital Larrey ( Site 0900)
Toulouse
31100
France
Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)
Balassagyarmat
2660
Hungary
Erzsebet Gondozohaz ( Site 1207)
Gödöllő
2100
Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1206)
Győr
9024
Hungary
Synexus Magyarorszag Kft. ( Site 1210)
Gyula
5700
Hungary
CRU Hungary KFT ( Site 1205)
Miskolc
3529
Hungary
Hillel Yaffe Medical Center ( Site 1303)
Hadera
3810101
Israel
Carmel Medical Center ( Site 1305)
Haifa
3436212
Israel
Meir Medical Center ( Site 1301)
Kfar Saba
4428164
Israel
Rabin Medical Center ( Site 1302)
Petah Tikva
4941492
Israel
Chaim Sheba Medical Center. ( Site 1304)
Ramat Gan
5265601
Israel
National Hospital Organization Nagoya Medical Center ( Site 1539)
Nagoya
Aichi-ken
460-0001
Japan
Nagoya City University Hospital ( Site 1528)
Nagoya
Aichi-ken
467-8602
Japan
National Hospital Organization Ehime Medical Center ( Site 1556)
Tōon
Ehime
791-0281
Japan
Idaimae Minamiyojo Int Clinic ( Site 1521)
Sapporo
Hokkaido
064-0804
Japan
Terada Clinic Respiratory Medicine & General Practice ( Site 1565)
Himeji
Hyōgo
670-0849
Japan
Kinki Central Hospital ( Site 1576)
Itami
Hyōgo
664-8533
Japan
Itami City Hospital ( Site 1580)
Itami
Hyōgo
664-8540
Japan
National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)
Naka-gun
Ibaraki
319-1113
Japan
Ishikawa Prefectural Central Hospital ( Site 1554)
Kanazawa
Ishikawa-ken
920-8530
Japan
Kanazawa University Hospital ( Site 1536)
Kanazawa
Ishikawa-ken
920-8641
Japan
Komatsu Municipal Hospital ( Site 1508)
Komatsu
Ishikawa-ken
923-8560
Japan
Kamei Internal Medicine and Respiratory Clinic ( Site 1509)
Takamatsu
Kagawa-ken
761-8073
Japan
Fujisawa City Hospital ( Site 1505)
Fujisawa
Kanagawa
251-8550
Japan
Yokohama City Minato Red Cross Hospital ( Site 1506)
Yokohama
Kanagawa
231-8682
Japan
Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)
Yokohama
Kanagawa
232-0064
Japan
Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)
Yokohama
Kanagawa
234-8503
Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 1503)
Yokohama
Kanagawa
236-0051
Japan
Matsusaka City Hospital ( Site 1525)
Matsusaka
Mie-ken
515-8544
Japan
Nagaoka Red Cross Hospital ( Site 1507)
Nagaoka
Niigata
940-2085
Japan
National Hospital Organization Minami-Okayama Medical Center ( Site 1553)
Tsukubo-gun
Okayama-ken
701-0304
Japan
Urasoe General Hospital ( Site 1572)
Urasoe
Okinawa
901-2132
Japan
Osaka Habikino Medical Center ( Site 1546)
Habikino
Osaka
583-8588
Japan
Kawaguchi Respiratory Clinic ( Site 1504)
Higashiosaka
Osaka
577-0843
Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)
Sakai
Osaka
591-8555
Japan
Tokyo Medical University Hachioji Medical Center ( Site 1569)
Hachiōji
Tokyo
193-0998
Japan
National Hospital Organization Tokyo National Hospital ( Site 1557)
Kiyose
Tokyo
204-8585
Japan
National Hospital Organization Disaster Medical Center ( Site 1558)
Tachikawa
Tokyo
190-0014
Japan
Shimonoseki City Hospital ( Site 1573)
Shimonoseki
Yamaguchi
750-8520
Japan
National Hospital Organization Fukuoka Hospital ( Site 1552)
Fukuoka
811-1394
Japan
Hiroshima Allergy & Respiratory Clinic ( Site 1529)
Hiroshima
732-0052
Japan
Kyoto University Hospital ( Site 1547)
Kyoto
606-8507
Japan
JA Niigatakoseiren Niigata Medical Center ( Site 1522)
Niigata
950-2022
Japan
Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)
Shizuoka
420-8527
Japan
Juntendo University Hospital ( Site 1578)
Tokyo
113-8431
Japan
Tokyo Shinagawa Hospital ( Site 1560)
Tokyo
140-8522
Japan
Showa University Hospital ( Site 1531)
Tokyo
142-8666
Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 1574)
Tokyo
162-8655
Japan
Tokyo Metropolitan Geriatric Hospital ( Site 1577)
Tokyo
173-0015
Japan
Clinica Ricardo Palma ( Site 1802)
San Isidro
Lima region
15036
Peru
Hospital Nacional Adolfo Guevara Velasco ( Site 1808)
Cusco
08006
Peru
Asociacion Civil por la Salud ( Site 1805)
Lima
15046
Peru
Hospital Chancay y Servicios Basicos de Salud ( Site 1810)
Lima
15131
Peru
Prywatny Gabinet Internistyczno ( Site 1928)
Bialystok
15-010
Poland
Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)
Bialystok
15-044
Poland
Centrum Medyczne Pratia Bydgoszcz ( Site 1418)
Bydgoszcz
85-796
Poland
Centrum Medyczne Pratia Czestochowa ( Site 1926)
Częstochowa
42-200
Poland
Centrum Medyczne Pratia Gdynia ( Site 1910)
Gdynia
81-338
Poland
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)
Krakow
30-033
Poland
USK nr 1 ( Site 1921)
Lodz
90-153
Poland
Prywatny Gabinet Specjalistyczny ( Site 1927)
Lodz
91-849
Poland
NZOZCentrum Medyczne Kermed ( Site 1905)
Żnin
88-400
Poland
Wonju Severance Christian Hospital ( Site 2214)
Wŏnju
Gangwon-do
26426
South Korea
Hallym University Sacred Heart Hospital ( Site 2208)
Anyang-si
Gyeonggi-do
14068
South Korea
Ajou University Hospital ( Site 2211)
Suwon
Gyeonggi-do
16499
South Korea
Incheon St. Mary s Hospital ( Site 2200)
Incheon
21431
South Korea
Seoul National University Hospital ( Site 2210)
Seoul
03080
South Korea
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)
Seoul
03312
South Korea
Severance Hospital ( Site 2204)
Seoul
03722
South Korea
Konkuk University Medical Center ( Site 2205)
Seoul
05030
South Korea
Asan Medical Center ( Site 2203)
Seoul
05505
South Korea
Samsung Medical Center ( Site 2212)
Seoul
06351
South Korea
The Catholic University of Korea St. Mary s Hospital ( Site 2215)
Seoul
06591
South Korea
Korea University Guro Hospital ( Site 2213)
Seoul
08308
South Korea
Hospital Clinic ( Site 2302)
Barcelona
08036
Spain
Hospital General Universitario Gregorio Maranon ( Site 2309)
Madrid
28007
Spain
Hospital Parc Tauli ( Site 2308)
Sabadell
08208
Spain
Hospital Clinico Universitario de Santiago ( Site 2303)
Santiago de Compostela
15706
Spain
Changhua Christian Hospital ( Site 2403)
Changhua
50006
Taiwan
Chang Gung Medical Foundation - Keelung Branch ( Site 2404)
Keelung
20401
Taiwan
Far Eastern Memorial Hospital ( Site 2402)
New Taipei City
22056
Taiwan
Taichung Veterans General Hospital ( Site 2401)
Taichung
407
Taiwan
National Taiwan University Hospital ( Site 2400)
Taipei
10002
Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)
Ankara
06100
Turkey (Türkiye)
I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)
Fatih
34098
Turkey (Türkiye)
Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)
Istanbul
34020
Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi ( Site 2611)
Kocaeli
41380
Turkey (Türkiye)
Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)
Rize
55200
Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)
Samsun
55139
Turkey (Türkiye)
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)
Kyiv
03680
Ukraine
City Polyclinic N20 ( Site 2822)
Odesa
65114
Ukraine
Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)
Vinnytsia
21001
Ukraine
Royal Preston Hospital ( Site 2709)
Preston
Lancashire
PR2 9HT
United Kingdom
Medinova Lakeside Dedicated Research Centre ( Site 2710)
Corby
Northamptonshire
NN17 2UR
United Kingdom
Belfast City Hospital ( Site 2705)
Belfast
BT9 7AB
United Kingdom
Broomfield Hospital ( Site 2722)
Chelmsford
CM1 7ET
United Kingdom
Glenfield Hospital ( Site 2701)
Leicester
LE3 9QP
United Kingdom
Royal Brompton Hospital ( Site 2703)
London
SW3 6JY
United Kingdom
Wythenshawe Hospital ( Site 2700)
Manchester
M23 9LT
United Kingdom
Churchill Hospital ( Site 2706)
Oxford
OX3 7LE
United Kingdom
Rothwell Medical Centre ( Site 2712)
Rothwell
NN14 6JQ
United Kingdom
MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)
Shipley
BD18 3SA
United Kingdom
Derived
McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.
FG002
Gefapixant 45 mg BID
Participants received 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.
FG000244 subjects
FG001244 subjects
FG002244 subjects
Treated
FG000243 subjects
FG001244 subjects
FG002243 subjects
COMPLETED
FG000199 subjects
FG001200 subjects
FG002184 subjects
NOT COMPLETED
FG00045 subjects
FG00144 subjects
FG00260 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0011 subjects
FG0020 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0021 subjects
Physician Decision
FG0002 subjects
FG0013 subjects
FG0023 subjects
Screen Failure
FG0001 subjects
FG0010 subjects
FG0021 subjects
Withdrawal by Subject
FG00037 subjects
FG00139 subjects
FG00255 subjects
Site Closure
FG0001 subjects
FG0010 subjects
FG0020 subjects
12-Week Off-Treatment Durability Period
Type
Comment
Milestone Data
STARTED
FG00010 subjectsNot all participants continued in the optional Off-Treatment Period.
FG00118 subjectsNot all participants continued in the optional Off-Treatment Period.
FG00213 subjectsNot all participants continued in the optional Off-Treatment Period.
COMPLETED
FG00010 subjects
FG00118 subjects
FG00213 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
BG001
Gefapixant 15 mg BID
Participants received 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.
BG002
Gefapixant 45 mg BID
Participants received 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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000244
BG001244
BG002244
BG003732
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG000244
ParticipantsBG001244
ParticipantsBG002244
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000244
ParticipantsBG001244
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000244
ParticipantsBG001244
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000244
ParticipantsBG001244
ParticipantsBG002
Geographic Region
Geographic region of enrollment with 5 categories: Asia-Pacific, Europe, North America, Others, and Missing.
Count of Participants
Participants
Title
Denominators
Categories
Asia Pacific
ParticipantsBG000244
ParticipantsBG001244
ParticipantsBG002
Baseline 24-hour Coughs per Hour
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). Baseline 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.
All participants with 24-hour Coughs per Hour data available at baseline.
Mean
Standard Deviation
coughs/hour
Title
Denominators
Categories
ParticipantsBG000232
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
All randomized participants in the analysis model who had taken at least 1 dose of study intervention and provided at least 1 baseline and at least 1 Week 12 24-hour cough observation during the treatment period were analyzed.
Posted
Geometric Mean
95% Confidence Interval
ratio
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Gefapixant 15 mg BID
Participants received 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.
OG002
Gefapixant 45 mg BID
Participants received 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.
Units
Counts
Participants
OG000222
OG001227
OG002217
Title
Denominators
Categories
Title
Measurements
OG0000.47(0.41 to 0.54)
OG0010.48(0.41 to 0.55)
OG0020.38(0.33 to 0.44)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.
ANCOVA
0.041
Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Estimated Percent Change Difference
-18.45
2-Sided
95
-32.92
-0.86
Other
Primary
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.
All randomized participants who received at least 1 dose of study intervention during the 52-week treatment period were analyzed. Per protocol, participants who continued in the optional Off-Treatment observational period were not included in the primary safety analysis.
Posted
Count of Participants
Participants
Up to approximately 54 weeks
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Gefapixant 15 mg BID
Participants received 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.
OG002
Gefapixant 45 mg BID
Primary
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.
All randomized participants who received at least 1 dose of study intervention during the 52-week treatment period were analyzed. Per protocol, participants who continued in the optional Off-Treatment observational period were not included in the primary safety analysis
Posted
Count of Participants
Participants
Up to approximately 52 weeks
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Gefapixant 15 mg BID
Participants received 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.
OG002
Gefapixant 45 mg BID
Secondary
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.
All randomized participants in the analysis model who had taken at least 1 dose of study intervention and provided at least 1 baseline and at least 1 Week 12 awake cough observation during the treatment period were analyzed.
Posted
Geometric Mean
95% Confidence Interval
ratio
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Gefapixant 15 mg BID
Participants received 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.
Secondary
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.
All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available 24-hour cough data at baseline and at least one available post-baseline measurement were analyzed.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Secondary
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.
All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available CSD data at baseline and at least one available post-baseline measurement were analyzed.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Secondary
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.
All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available CSD data at baseline and at least one available post-baseline measurement were analyzed.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Secondary
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.
All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available Cough Severity VAS data at baseline and at least one available post-baseline measurement were analyzed.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Secondary
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.
All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available LCQ data at baseline and at least one available post-baseline measurement were analyzed.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
OG001
Gefapixant 15 mg BID
Time Frame
On-Treatment Period (plus 2-week telephone follow-up): Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
Description
All-Cause Mortality reported for all randomized participants by applicable treatment period. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug during the Treatment Period. AEs were reported for a participant separately during the Treatment Period (MedDRA 23.0) and optional Off-Tx Period (MedDRA 23.1). Per protocol, only All-Cause Mortality, drug-related serious and nonserious AEs, and pregnancies were monitored during the Off-Tx Period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
2
244
14
243
129
243
EG001
Gefapixant 15 mg BID
Participants received 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.
1
244
17
244
140
244
EG002
Gefapixant 45 mg BID
Participants received 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.
0
244
13
243
179
243
EG003
Placebo: Off-Tx
Participants previously treated with dose-matched placebo BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
0
10
0
10
0
10
EG004
Gefapixant 15 mg BID: Off-Tx
Participants previously treated with gefapixant 15 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
0
18
0
18
1
18
EG005
Gefapixant 45 mg BID: Off-Tx
Participants previously treated with gefapixant 45 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
0
13
0
13
1
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected13 at risk
Cardiac amyloidosis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Abdominal wall cyst
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Accidental death
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Death
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Papilloma viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Traumatic haemothorax
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Malignant neoplasm of ampulla of Vater
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0010 events0 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Temporal arteritis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0010 events0 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0011 events1 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00019 events14 affected243 at risk
EG00119 events15 affected244 at risk
EG00223 events12 affected243 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected13 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0007 events6 affected243 at risk
EG0017 events7 affected244 at risk
EG00213 events13 affected243 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00022 events13 affected243 at risk
EG0018 events8 affected244 at risk
EG00220 events17 affected243 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00012 events11 affected243 at risk
EG00125 events20 affected244 at risk
EG00217 events11 affected243 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0011 events1 affected244 at risk
EG0021 events1 affected243 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00075 events51 affected243 at risk
EG00160 events47 affected244 at risk
EG00263 events50 affected243 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0012 events2 affected244 at risk
EG0020 events0 affected243 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00012 events9 affected243 at risk
EG00120 events18 affected244 at risk
EG00219 events13 affected243 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00014 events11 affected243 at risk
EG00114 events14 affected244 at risk
EG00213 events9 affected243 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0008 events8 affected243 at risk
EG00118 events13 affected244 at risk
EG00212 events9 affected243 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00021 events19 affected243 at risk
EG00117 events14 affected244 at risk
EG00227 events20 affected243 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected243 at risk
EG0015 events3 affected244 at risk
EG00237 events33 affected243 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0009 events8 affected243 at risk
EG00125 events22 affected244 at risk
EG002101 events88 affected243 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00055 events31 affected243 at risk
EG00157 events34 affected244 at risk
EG00251 events29 affected243 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected243 at risk
EG0015 events5 affected244 at risk
EG00214 events13 affected243 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected243 at risk
EG0012 events2 affected244 at risk
EG00224 events24 affected243 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00021 events16 affected243 at risk
EG00110 events9 affected244 at risk
EG00218 events11 affected243 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00011 events10 affected243 at risk
EG00114 events14 affected244 at risk
EG00217 events16 affected243 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00014 events10 affected243 at risk
EG00118 events13 affected244 at risk
EG00214 events14 affected243 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission to allow the Sponsor to protect proprietary information and comment.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.
ANCOVA
0.874
Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Estimated Percent Change Difference
1.56
2-Sided
95
-16.13
22.99
Other
Participants received 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.
Units
Counts
Participants
OG000243
OG001244
OG002243
Title
Denominators
Categories
Title
Measurements
OG000184
OG001186
OG002208
Participants received 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.
Units
Counts
Participants
OG000243
OG001244
OG002243
Title
Denominators
Categories
Title
Measurements
OG00014
OG00115
OG00251
OG002
Gefapixant 45 mg BID
Participants received 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.
Units
Counts
Participants
OG000222
OG001227
OG002217
Title
Denominators
Categories
Title
Measurements
OG0000.46(0.40 to 0.53)
OG0010.47(0.41 to 0.55)
OG0020.38(0.33 to 0.44)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.
ANCOVA
0.056
Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Estimated Percent Change Difference
-17.68
2-Sided
95
-32.57
0.50
Other
OG000
OG001
Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.
ANCOVA
0.770
Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Estimated Percent Change Difference
2.95
2-Sided
95
-15.33
25.19
Other
Gefapixant 15 mg BID
Participants received 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.
OG002
Gefapixant 45 mg BID
Participants received 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.
Units
Counts
Participants
OG000222
OG001227
OG002217
Title
Denominators
Categories
Title
Measurements
OG00065.9
OG00166.2
OG00269.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.
Regression, Logistic
0.416
Odds Ratio (OR)
1.20
2-Sided
95
0.77
1.86
Other
OG000
OG001
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.
Regression, Logistic
0.948
Odds Ratio (OR)
1.01
2-Sided
95
0.66
1.55
Other
Gefapixant 15 mg BID
Participants received 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.
OG002
Gefapixant 45 mg BID
Participants received 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.
Units
Counts
Participants
OG000237
OG001241
OG002234
Title
Denominators
Categories
Title
Measurements
OG00052.4
OG00162.1
OG00260.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.
Odds Ratio (OR)
1.39
2-Sided
95
0.94
2.05
Other
OG000
OG001
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.
Odds Ratio (OR)
1.48
2-Sided
95
1.01
2.18
Other
Gefapixant 15 mg BID
Participants received 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.
OG002
Gefapixant 45 mg BID
Participants received 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.
Units
Counts
Participants
OG000237
OG001241
OG002234
Title
Denominators
Categories
Title
Measurements
OG00028.6
OG00137.9
OG00240.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.
Odds Ratio (OR)
1.68
2-Sided
95
1.11
2.54
Other
OG000
OG001
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.
Odds Ratio (OR)
1.53
2-Sided
95
1.01
2.30
Other
Gefapixant 15 mg BID
Participants received 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.
OG002
Gefapixant 45 mg BID
Participants received 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.
Units
Counts
Participants
OG000237
OG001241
OG002234
Title
Denominators
Categories
Title
Measurements
OG00031.3
OG00136.7
OG00241.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.
Odds Ratio (OR)
1.54
2-Sided
95
1.03
2.30
Other
OG000
OG001
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.
Odds Ratio (OR)
1.27
2-Sided
95
0.86
1.89
Other
Participants received 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.
OG002
Gefapixant 45 mg BID
Participants received 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.
Units
Counts
Participants
OG000217
OG001226
OG002214
Title
Denominators
Categories
Title
Measurements
OG00061.3
OG00168.8
OG00267.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.
Odds Ratio (OR)
1.30
2-Sided
95
0.85
1.98
Other
OG000
OG001
Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.