A Study of Gefapixant (MK-7264) in Adult Participants Wit... | NCT03449147 | Trialant
NCT03449147
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 2, 2021Actual
Enrollment
1,317Actual
Phase
Phase 3
Conditions
Chronic Cough
Interventions
Placebo
Gefapixant 15 mg BID
Gefapixant 45 mg BID
Countries
United States
Australia
Canada
China
Colombia
Czechia
Denmark
Germany
Guatemala
Hungary
Israel
Italy
Malaysia
New Zealand
Peru
Poland
South Africa
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03449147
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7264-030
Secondary IDs
ID
Type
Description
Link
MK-7264-030
Other Identifier
Merck Protocol Number
2017-003559-49
EudraCT Number
Brief Title
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 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 15, 2018Actual
Primary Completion Date
Aug 20, 2020Actual
Completion Date
Oct 30, 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
Aug 9, 2021
Results First Submitted that Met QC Criteria
Aug 9, 2021
Results First Posted Date
Sep 2, 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
Aug 9, 2021
Last Update Posted Date
Sep 2, 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 primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
Detailed Description
This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 12-week, Off-treatment Durability Study Period. Any assessments conducted in the observational period will be exploratory.
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
1,317Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants will receive a matching placebo tablet BID during the 24-week main study period and the 28-week extension period.
Drug: Placebo
Gefapixant 15 mg BID
Experimental
Participants will receive a gefapixant 15 mg tablet BID and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and the 28-week extension period.
Drug: Placebo
Drug: Gefapixant 15 mg BID
Gefapixant 45 mg BID
Experimental
Participants will receive a gefapixant 45 mg tablet BID and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and during the 28-week extension period.
Drug: Placebo
Drug: Gefapixant 45 mg BID
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo tablet administered orally BID
Gefapixant 15 mg BID
Gefapixant 45 mg BID
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
Baseline, Week 24
Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to 54 Weeks
Number of Participants Who Discontinued a Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.
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
Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)
Exclusion Criteria:
Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
Has a history of chronic bronchitis
Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR an eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
Has a history of malignancy ≤5 years
Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
Has a known allergy/sensitivity or contraindication to gefapixant
Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
Has previously received gefapixant
Currently participating in or has participated in an interventional clinical study within 30 days of 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.
1317 participants were randomized to the 52-week treatment period, and 1314 participants received at least 1 dose of study intervention. After the main study, 122 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 24-week main study period and 28-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 24-week main study period and 28-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
No data available
No data is available for this block.
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: gefapixant 45 mg twice daily (BID), gefapixant 15 mg BID, or placebo.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Gefapixant 15 mg BID
Drug
Gefapixant 15 mg tablet administered orally BID
Gefapixant 15 mg BID
MK-7264
Gefapixant 45 mg BID
Drug
Gefapixant 45 mg tablet administered orally BID
Gefapixant 45 mg BID
MK-7264
Baseline, Week 24
Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented.
Baseline, Week 24
Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A clinically meaningful improvement from baseline is defined as a ≤-30% change (≥30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
Baseline, Week 24
Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-1.3 point change from baseline in CSD at Week 24 (or ≥1.3 point reduction from baseline) is reported.
Baseline, Week 24
Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-2.7 point change from baseline in CSD at Week 24 (or ≥2.7 point reduction from baseline) is reported.
Baseline, Week 24
Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-30 mm change from baseline in cough severity VAS score at Week 24 is reported.
Baseline, Week 24
Phoenix
Arizona
85006
United States
Clinical Research Consortium ( Site 0088)
Tempe
Arizona
85283
United States
Allergy & Asthma Associates of SCV Research Center ( Site 0064)
San Jose
California
95117
United States
Lenus Research & Medical Group Llc ( Site 0075)
Sweetwater
Florida
33172
United States
Atlanta Allergy & Asthma Clinic PA ( Site 0029)
Stockbridge
Georgia
30281
United States
Rush University Medical Center ( Site 0103)
Chicago
Illinois
60612
United States
Healthcare Research Network LLC ( Site 0093)
Flossmoor
Illinois
60422
United States
Abraham Research, PLLC ( Site 0107)
Fort Mitchell
Kentucky
41017
United States
Paul A. Shapero, MD ( Site 0104)
Bangor
Maine
04401
United States
Bethesda Allergy Asthma and Research Center LLC ( Site 0019)
Bethesda
Maryland
20814
United States
Respiratory Medicine Research Institute of Michigan, PLC ( Site 0034)
Ypsilanti
Michigan
48197
United States
Minnesota Lung Center ( Site 0108)
Edina
Minnesota
55435
United States
Mayo Clinic - Rochester ( Site 0006)
Rochester
Minnesota
55905
United States
Minnesota Lung Center ( Site 0041)
Woodbury
Minnesota
55125
United States
The Lung Research Center ( Site 0072)
Chesterfield
Missouri
63017
United States
University of Missouri ENT & Allergy Center ( Site 0066)
Columbia
Missouri
65201
United States
CHI Health Creighton University Medical Center ( Site 0024)
Omaha
Nebraska
68134
United States
Clinical Research Consortium ( Site 0050)
Las Vegas
Nevada
89109
United States
Atlantic Research Center LLC ( Site 0012)
Ocean City
New Jersey
07712
United States
Albuquerque Clinical Trials ( Site 0039)
Albuquerque
New Mexico
87102
United States
Montefiore Medical Center ( Site 0098)
The Bronx
New York
10461
United States
Wake Research Associates, LLC ( Site 0058)
Raleigh
North Carolina
27612
United States
Remington-Davis, Inc. ( Site 0082)
Columbus
Ohio
43215
United States
Clinical Research Institute of Southern Oregon, PC ( Site 0099)
Medford
Oregon
97504
United States
Allergy Associates Research Center ( Site 0026)
Portland
Oregon
97202
United States
AAPRI Clinical Research Institute ( Site 0001)
Warwick
Rhode Island
02886
United States
Lowcountry Lung & Critical Care, PA ( Site 0045)
Charleston
South Carolina
29406
United States
Allergic Disease and Asthma Center ( Site 0043)
Greenville
South Carolina
29607
United States
Clinical Research of Rock Hill ( Site 0079)
Rock Hill
South Carolina
29732
United States
Clinical Research Partners, LLC. ( Site 0080)
Richmond
Virginia
23235
United States
Bellingham Asthma & Allergy ( Site 0076)
Bellingham
Washington
98225
United States
Marycliff Clinical Research ( Site 0062)
Spokane
Washington
99202
United States
Multicare Health System ( Site 0018)
Tacoma
Washington
98405
United States
Australian Clinical Research Network ( Site 0201)
Maroubra
New South Wales
2035
Australia
Holdsworth House Medical Practice ( Site 0206)
Sydney
New South Wales
2010
Australia
Royal Adelaide Hospital [Adelaide, Australia] ( Site 0214)
Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft ( Site 1203)
Püspökladány
4150
Hungary
Kaplan Medical Center ( Site 1300)
Rehovot
7661041
Israel
Azienda Ospedaliero Universitaria Careggi ( Site 1400)
Florence
50134
Italy
Hospital Sultanah Bahiyah ( Site 1607)
Alor Star
Kedah
05460
Malaysia
Hospital Taiping ( Site 1600)
Taiping
Perak
34000
Malaysia
Hospital Pulau Pinang. ( Site 1606)
George Town
Pulau Pinang
10990
Malaysia
Universiti Teknologi MARA ( Site 1602)
Batu Caves
Selangor
68100
Malaysia
Institut Perubatan Respiratori ( Site 1605)
Kuala Lumpur
53000
Malaysia
University Malaya Medical Centre ( Site 1601)
Kuala Lumpur
59100
Malaysia
Southern Clinical Trials - Waitemata ( Site 0230)
Auckland
0626
New Zealand
Middlemore Clinical Trials ( Site 0232)
Auckland
2025
New Zealand
Lakeland Clinical Trials ( Site 0233)
Rotorua
3010
New Zealand
P3 Research Ltd. ( Site 0228)
Tauranga
3110
New Zealand
Clinica Ricardo Palma ( Site 1802)
San Isidro
Lima region
15036
Peru
Hospital Nacional Adolfo Guevara Velasco ( Site 1808)
Cusco
08000
Peru
Clinica Internacional ( Site 1801)
Lima
15001
Peru
Asociacion Civil por la Salud ( Site 1805)
Lima
15046
Peru
Hospital Nacional Cayetano Heredia [Lima, Peru] ( Site 1806)
Lima
15102
Peru
NZOZ CENTRUM ALERGOLOGII ( Site 1909)
Lublin
Lublin Voivodeship
20-552
Poland
Centrum Medyczne Pratia Katowice ( Site 1917)
Katowice
Silesian Voivodeship
40-081
Poland
Centrum Medyczne Silmedic Sp z o o ( Site 1920)
Katowice
Silesian Voivodeship
40-282
Poland
Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)
Bialystok
15-044
Poland
KLIMED ( Site 1902)
Bychawa
23-100
Poland
Gyncentrum Clinic Sp. z o.o. ( Site 1908)
Katowice
40-851
Poland
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)
Krakow
30-033
Poland
Centrum Nowoczesnych Terapii Dobry Lekarz ( Site 1924)
Krakow
31-011
Poland
Uniwersytecki Szpital Kliniczny im. Norberta Barlickiego nr 1 ( Site 1921)
Lodz
90-141
Poland
Ostrowieckie Centrum Medyczne ( Site 1915)
Ostrowiec Świętokrzyski
27-400
Poland
RCMed ( Site 1912)
Sochaczew
96-500
Poland
Lubelskie Centrum Diagnostyczne ( Site 1913)
Åšwidnik
21-040
Poland
Centrum Medyczne Pratia Warszawa ( Site 1911)
Warsaw
01-868
Poland
Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1923)
Zawadzkie
47-120
Poland
Iatros International ( Site 2130)
Brandwag
Bloemfontein
9301
South Africa
Rochester Place Medical Centre ( Site 2129)
Morningside
Gauteng
2196
South Africa
Jongaie Research ( Site 2131)
Pretoria
Gauteng
0183
South Africa
Dr N K Gounden Mediclinic ( Site 2134)
Shallcross
KwaZulu-Natal
4093
South Africa
Drs Lalloo & Ambaram ( Site 2132)
Umhlanga Ridge
KwaZulu-Natal
4319
South Africa
I Engelbrecht Research ( Site 2128)
Centurion
Tswane
0157
South Africa
UCT Lung Institute - Bateman ( Site 2126)
Cape Town
Western Cape
7700
South Africa
Uludag Universitesi Tip Fakultesi ( Site 2621)
Bursa
Gorukle
16059
Turkey (Türkiye)
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2612)
Adana
01330
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2602)
Ankara
06100
Turkey (Türkiye)
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi ( Site 2619)
Edirne
22030
Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Gogus Hastalıklari ABD ( Site 2610)
Istanbul
34093
Turkey (Türkiye)
SSK Sureyyapasa Gogus Hastaliklari Hastanesi ( Site 2608)
Istanbul
34844
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2603)
Izmir
35040
Turkey (Türkiye)
SBU Dr. Suat Seren Gogus Hast. ve Cer. Egitim ve Arastirma Hast. ( Site 2604)
Izmir
35110
Turkey (Türkiye)
Celal Bayar University Faculty of Medicine ( Site 2614)
Manisa
45030
Turkey (Türkiye)
Chernihiv City hospital N2 ( Site 2801)
Chernihiv
14034
Ukraine
CE Chernivtsi state city clinical hospital 3 ( Site 2806)
Chernivtsi
58022
Ukraine
Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2812)
Kherson
73000
Ukraine
Medical Clinic Blagomed LLC ( Site 2807)
Kiev
01023
Ukraine
Kyiv City Tuberculosis Hospital No. 1 ( Site 2814)
Kyiv
02091
Ukraine
Medical Association Medbud of the PJSC Kyivmiskbud ( Site 2803)
Kyiv
03037
Ukraine
SE Road Clinical Hospital 2 of Kyiv station ( Site 2809)
Kyiv
03049
Ukraine
Institute of Otolaryngology n. a. Prof. A. I. Kolomiychenko ( Site 2833)
Kyiv
03067
Ukraine
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2804)
Kyiv
03680
Ukraine
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)
Kyiv
03680
Ukraine
Volyn Regional Clinical Hospital ( Site 2829)
Lutsk
43005
Ukraine
Poltava City Clinical Hospital 1 ( Site 2808)
Poltava
36039
Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2819)
Vinnytsia
21018
Ukraine
MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2811)
Zaporizhzhia
69065
Ukraine
Zhytomyr Central City Hospital #1 ( Site 2828)
Zhytomyr
10002
Ukraine
Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 2704)
Cottingham
East Yorkshire
HU16 5JQ
United Kingdom
Synexus Midlands Clinical Research Centre Ltd ( Site 2719)
Birmingham
Edgbaston
B15 2SQ
United Kingdom
Medinova East London Dedicated Research Centre ( Site 2715)
Romford
Essex
RM1 3PJ
United Kingdom
Medinova South London Dedicated Research Centre ( Site 2714)
Sidcup
Kent
DA14 6LT
United Kingdom
Medinova North London Dedicated Research Centre ( Site 2716)
Northwood
Middlesex
HA6 2RN
United Kingdom
Medinova Lakeside Dedicated Research Centre ( Site 2710)
Corby
Northamptonshire
NN17 2UR
United Kingdom
Medinova Warwickshire Dedicated Research Centre ( Site 2717)
Kenilworth
Warwickshire
CV8 1JD
United Kingdom
Belfast City Hospital ( Site 2705)
Belfast
BT9 7AB
United Kingdom
Synexus Scotland Clinical Research Centre ( Site 2721)
Glasgow
G20 0SP
United Kingdom
Synexus Merseyside Clinical Research Centre ( Site 2720)
Liverpool
L22 OLG
United Kingdom
Prince Phillip Hospital ( Site 2722)
Llanelli
SA14 8QF
United Kingdom
1Kings College Hospital ( Site 2702)
London
SE5 9RS
United Kingdom
Synexus Manchester Clinical Research Centre ( Site 2718)
Manchester
M15 6SE
United Kingdom
Wythenshawe Hospital ( Site 2700)
Manchester
M23 9LT
United Kingdom
North Tyneside General Hospital ( Site 2707)
North Shields
NE29 8NH
United Kingdom
Rothwell Medical Centre ( Site 2712)
Rothwell
NN14 6JQ
United Kingdom
Taunton and Somerset Hospital ( Site 2723)
Taunton
TA1 5DA
United Kingdom
West Walk Surgery ( Site 2711)
Yate
BS37 4AX
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 24-week main study period and 28-week extension period.
FG000436 subjects
FG001442 subjects
FG002439 subjects
COMPLETED
FG000382 subjects
FG001368 subjects
FG002355 subjects
NOT COMPLETED
FG00054 subjects
FG00174 subjects
FG00284 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
Lost to Follow-up
FG0006 subjects
FG0012 subjects
FG0025 subjects
Other
FG0000 subjects
FG0011 subjects
FG0022 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0023 subjects
Screen Failure
FG0001 subjects
FG0012 subjects
FG0020 subjects
Withdrawal by Subject
FG00046 subjects
FG00168 subjects
FG00274 subjects
12-Week Off-Treatment Durability Period
Type
Comment
Milestone Data
STARTED
FG00048 subjectsNot all participants continued in the optional Off-Treatment Period.
FG00137 subjectsNot all participants continued in the optional Off-Treatment Period.
FG00237 subjectsNot all participants continued in the optional Off-Treatment Period.
COMPLETED
FG00047 subjects
FG00136 subjects
FG00237 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
Other
FG000
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 24-week main study period and 28-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 24-week main study period and 28-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 24-week main study period and 28-week extension period.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000436
BG001442
BG002439
BG0031317
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
ParticipantsBG000436
ParticipantsBG001442
ParticipantsBG002439
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000436
ParticipantsBG001442
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000436
ParticipantsBG001442
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000436
ParticipantsBG001442
ParticipantsBG002
Baseline 24-Hour Coughs Per Hour
24-hour coughs per hour is defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor).
All participants with 24-hour coughs per hour data available at baseline
Mean
Standard Deviation
Coughs/Hour
Title
Denominators
Categories
ParticipantsBG000432
ParticipantsBG001431
ParticipantsBG002
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 Coughs Per Hour at Week 24/Baseline
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
All randomized participants who took at least 1 dose of study intervention, had available 24-hour cough data at baseline and at least one available post-baseline measurement during the treatment period.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-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 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000419
OG001415
OG002409
Title
Denominators
Categories
Title
Measurements
OG0000.43(0.39 to 0.48)
OG0010.43(0.38 to 0.47)
OG0020.37(0.33 to 0.41)
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
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 24 based on log transformed data.
ANCOVA
0.875
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 Relative Reduction (%)
-1.14
2-Sided
95
-14.27
14.02
Superiority
Primary
Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
All randomized participants who received at least one dose of study intervention during the 52-week treatment period. Per protocol, participants in the optional off-treatment observational period were not included. 3 participants randomized to placebo group who took 1 or more incorrect dose(s) of study drug were counted in the higher dose group of gefapixant received: 2 participants were analyzed in the gefapixant 15 mg group and 1 was analyzed in the gefapixant 45 mg group.
Posted
Count of Participants
Participants
Up to 54 Weeks
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-week extension period.
Primary
Number of Participants Who Discontinued a Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
All randomized participants who received at least one dose of study intervention during the 52-week treatment period. Per protocol, participants in the optional off-treatment observational period were not included. 3 participants randomized to placebo group who took 1 or more incorrect dose(s) of study drug were counted in the higher dose group of gefapixant received: 2 participants were analyzed in the gefapixant 15 mg group and 1 was analyzed in the gefapixant 45 mg group.
Posted
Count of Participants
Participants
Up to 52 weeks
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-week extension period.
Secondary
Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.
All randomized participants who took at least 1 dose of study intervention, had available awake 24-hour cough data at baseline and at least one available post-baseline measurement during the treatment period.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-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 24-week main study period and 28-week extension period.
Secondary
Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented.
All randomized participants who had taken at least 1 dose of study intervention, had available LCQ data at baseline, and at least one available post-baseline measurement in the treatment period.
Posted
Number
Percentage of Participants
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-week extension period.
OG002
Secondary
Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A clinically meaningful improvement from baseline is defined as a ≤-30% change (≥30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
All randomized participants who took at least 1 dose of study intervention, had available 24-hour cough data at baseline and at least one available post-baseline measurement in the treatment period.
Posted
Number
Percentage of Participants
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-week extension period.
OG002
Gefapixant 45 mg BID
Secondary
Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-1.3 point change from baseline in CSD at Week 24 (or ≥1.3 point reduction from baseline) is reported.
All randomized participants who had taken at least 1 dose of study intervention, had available CSD data at baseline, and at least one available post-baseline measurement in the treatment period.
Posted
Number
Percentage of Participants
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-week extension period.
OG002
Secondary
Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-2.7 point change from baseline in CSD at Week 24 (or ≥2.7 point reduction from baseline) is reported.
All randomized participants who had taken at least 1 dose of study intervention, had available CSD data at baseline, and at least one available post-baseline measurement in the treatment period.
Posted
Number
Percentage of Participants
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-week extension period.
OG002
Secondary
Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-30 mm change from baseline in cough severity VAS score at Week 24 is reported.
All randomized participants who had taken at least 1 dose of study intervention, had available VAS data at baseline, and at least one available post-baseline measurement in the treatment period.
Posted
Number
Percentage of participants
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-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 24-week main study period and 28-week extension period.
OG002
Gefapixant 45 mg
Time Frame
On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
Description
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
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 24-week main study period and 28-week extension period.
0
433
25
432
248
432
EG001
Gefapixant 15 mg BID
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
1
444
24
442
290
442
EG002
Gefapixant 45 mg BID
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
0
440
25
440
359
440
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
48
0
48
6
48
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
37
0
37
3
37
EG005
Gefapixant 45 mg BID: Off Tx
Participants previously treated with gefapixant 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
37
1
37
1
37
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG0030 events0 affected48 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected37 at risk
Arrhythmia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Congenital choroid plexus cyst
Congenital, familial and genetic disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0012 events2 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0013 events3 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Tonsillitis bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Disinfectant poisoning
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Spinal meningioma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Hypertensive encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Stress
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0011 events1 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Laryngeal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0010 events0 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0011 events1 affected442 at risk
EG0020 events0 affected440 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected432 at risk
EG0010 events0 affected442 at risk
EG0021 events1 affected440 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00020 events18 affected432 at risk
EG00129 events27 affected442 at risk
EG00234 events27 affected440 at risk
EG0030 events0 affected48 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected37 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00012 events11 affected432 at risk
EG00115 events15 affected442 at risk
EG00234 events32 affected440 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00042 events32 affected432 at risk
EG00133 events26 affected442 at risk
EG00257 events47 affected440 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00027 events23 affected432 at risk
EG00124 events20 affected442 at risk
EG00219 events18 affected440 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00045 events35 affected432 at risk
EG00135 events29 affected442 at risk
EG00227 events24 affected440 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG000101 events70 affected432 at risk
EG001128 events93 affected442 at risk
EG00295 events70 affected440 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00020 events18 affected432 at risk
EG00125 events23 affected442 at risk
EG00216 events14 affected440 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00032 events26 affected432 at risk
EG00147 events38 affected442 at risk
EG00239 events30 affected440 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00027 events23 affected432 at risk
EG00140 events34 affected442 at risk
EG00226 events19 affected440 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00037 events30 affected432 at risk
EG00126 events22 affected442 at risk
EG00225 events21 affected440 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00033 events25 affected432 at risk
EG00134 events30 affected442 at risk
EG00217 events16 affected440 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected432 at risk
EG00114 events13 affected442 at risk
EG00275 events67 affected440 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00030 events28 affected432 at risk
EG00164 events56 affected442 at risk
EG002220 events193 affected440 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG000128 events67 affected432 at risk
EG001131 events74 affected442 at risk
EG002131 events70 affected440 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected432 at risk
EG00118 events17 affected442 at risk
EG00260 events60 affected440 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected432 at risk
EG0018 events8 affected442 at risk
EG00239 events37 affected440 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00013 events11 affected432 at risk
EG00118 events13 affected442 at risk
EG00229 events19 affected440 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00020 events18 affected432 at risk
EG00137 events30 affected442 at risk
EG00238 events31 affected440 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00021 events19 affected432 at risk
EG00113 events13 affected442 at risk
EG00224 events23 affected440 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
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
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 24 based on log transformed data.
ANCOVA
0.031
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 Relative Reduction (%)
-14.64
2-Sided
95
-26.07
-1.43
Superiority
OG002
Gefapixant 45 mg BID
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000432
OG001442
OG002440
Title
Denominators
Categories
Title
Measurements
OG000349
OG001373
OG002399
OG002
Gefapixant 45 mg BID
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000432
OG001442
OG002440
Title
Denominators
Categories
Title
Measurements
OG00025
OG00140
OG002100
Units
Counts
Participants
OG000419
OG001415
OG002409
Title
Denominators
Categories
Title
Measurements
OG0000.42(0.38 to 0.47)
OG0010.41(0.37 to 0.46)
OG0020.36(0.32 to 0.40)
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
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 24 based on log transformed data.
ANCOVA
0.677
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 Relative Reduction (%)
-3.03
2-Sided
95
-16.14
12.12
Superiority
OG000
OG002
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 24 based on log transformed data.
ANCOVA
0.022
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 Relative Reduction (%)
-15.79
2-Sided
95
-27.27
-2.50
Superiority
Gefapixant 45 mg
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000406
OG001404
OG002399
Title
Denominators
Categories
Title
Measurements
OG00070.1
OG00175.9
OG00276.8
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
OG001
Regression, Logistic
0.077
Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.
Odds Ratio (OR)
1.34
2-Sided
95
0.97
1.85
Superiority
OG000
OG002
Regression, Logistic
0.040
Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.
Odds Ratio (OR)
1.41
2-Sided
95
1.02
1.96
Superiority
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000419
OG001415
OG002409
Title
Denominators
Categories
Title
Measurements
OG00066.9
OG00167.4
OG00272.9
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
OG001
Regression, Logistic
0.872
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.
Odds Ratio (OR)
1.03
2-Sided
95
0.75
1.40
Superiority
OG000
OG002
Regression, Logistic
0.082
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.
Odds Ratio (OR)
1.33
2-Sided
95
0.96
1.83
Superiority
Gefapixant 45 mg
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000428
OG001426
OG002425
Title
Denominators
Categories
Title
Measurements
OG00069.1
OG00174.8
OG00277.1
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
OG001
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Odds Ratio (OR)
1.33
2-Sided
95
0.96
1.83
Other
OG000
OG002
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Odds Ratio (OR)
1.50
2-Sided
95
1.08
2.09
Other
Gefapixant 45 mg
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000428
OG001426
OG002425
Title
Denominators
Categories
Title
Measurements
OG00041.0
OG00146.6
OG00255.2
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
OG001
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Odds Ratio (OR)
1.25
2-Sided
95
0.93
1.69
Other
OG000
OG002
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Odds Ratio (OR)
1.77
2-Sided
95
1.31
2.39
Other
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
Units
Counts
Participants
OG000428
OG001426
OG002425
Title
Denominators
Categories
Title
Measurements
OG00040.9
OG00151.4
OG00253.3
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
OG001
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.
Odds Ratio (OR)
1.53
2-Sided
95
1.14
2.05
Other
OG000
OG002
Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.