A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03696108
• Collaborator: (none)
• Enrollment: 175
• Locations: 61
• Arms: 2
• Actual Duration (Months): 23.2
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety of two doses of gefapixant (MK-7264) in Japanese adult participants with refractory or unexplained chronic cough.

Condition or Disease	Intervention/Treatment	Phase
Chronic Cough	Drug: Gefapixant; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Double-blind Clinical Study to Evaluate the Long-term Safety and Efficacy of MK-7264 in Japanese Adult Participants With Refractory or Unexplained Chronic Cough
• Actual Study Start Date: Oct 31, 2018
• Actual Primary Completion Date: Oct 7, 2020
• Actual Study Completion Date: Oct 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gefapixant 15 mg BID Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks).	Drug: Gefapixant; Gefapixant 15 mg or 45 mg tablet administered orally BID; Other Names: MK-7264 ; Drug: Placebo; Placebo matched to gefapixant 15 mg or 45 mg administered orally BID
Experimental: Gefapixant 45 mg BID Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks).	Drug: Gefapixant; Gefapixant 15 mg or 45 mg tablet administered orally BID; Other Names: MK-7264 ; Drug: Placebo; Placebo matched to gefapixant 15 mg or 45 mg administered orally BID

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced at Least One Adverse Event (AE) [Up to 54 Weeks]

   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.

2. Number of Participants Who Discontinued Study Drug Due to an AE [Up to 52 Weeks]

   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.

Secondary Outcome Measures

1. Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 [Baseline, Week 12]

   The LCQ is a 19-item cough-specific health-related quality of life (HRQoL) questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model.

2. Change From Baseline in LCQ Total Score [Baseline, up to 52 Weeks]

   The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model at weeks 4, 8, 12, 24, 38 and 52 of treatment.

3. Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score [Baseline, Up to 52 Weeks]

   The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. 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 weeks 4, 8, 12, 24, 38 and 52 of treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chest radiograph or computed tomography scan of the thorax 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.

• Chronic cough for ≥ 4 months and a diagnosis of refractory or unexplained chronic cough.

• Persistent cough, despite treatment in accordance with the latest guideline of cough from the Japanese Respiratory Society, cough is a burden to the participant, and needs further treatment.

• If female, is not pregnant, not breast-feeding, and either is not a woman of childbearing potential or agrees to follow the contraceptive guidance.

Exclusion Criteria:

• Current smoker, or has given up smoking within 12 months of Screening.

• History of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status.

• Has a history of chronic bronchitis.

• Current use of an angiotensin converting enzyme inhibitor (ACEI) or has taken an ACEI within 3 months of Screening.

• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^{2 OR ≥30 mL/min/1.73 m}2 and <50 mL/min/1.73 m^2 at Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Visit 1).

• History of malignancy ≤ 5 years.

• User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.

• Systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg at Screening.

• History of cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs.

• Known allergy/sensitivity or contraindication to gefapixant.

• Donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant.

• Previously received gefapixant or is currently participating in or has participated in an interventional clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chubu Rosai Hospital ( Site 3839)	Nagoya	Aichi	Japan	455-8530
2	National Hospital Organization Nagoya Medical Center ( Site 3898)	Nagoya	Aichi	Japan	460-0001
3	Nagoya City University Hospital ( Site 3899)	Nagoya	Aichi	Japan	467-8602
4	Fukuoka University Chikushi Hospital ( Site 3886)	Chikushino	Fukuoka	Japan	818-8502
5	Oishi Clinic ( Site 3818)	Kasuya-gun	Fukuoka	Japan	811-2310
6	National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)	Koga	Fukuoka	Japan	811-3195
7	Nagata Hospital ( Site 3815)	Yanagawa	Fukuoka	Japan	832-0059
8	Tohno Chuo Clinic ( Site 3883)	Mizunami	Gifu	Japan	509-6134
9	National Hospital Organization Shibukawa Medical Center ( Site 3843)	Shibukawa	Gunma	Japan	377-0280
10	Idaimae Minamiyojo Int Clinic ( Site 3903)	Sapporo	Hokkaido	Japan	064-0804
11	Terada Clinic Respiratory Medicine & General Practice ( Site 3907)	Himeji	Hyogo	Japan	670-0849
12	Kinki Central Hospital ( Site 3910)	Itami	Hyogo	Japan	664-8533
13	Kobe City Hospital Organization Kobe City Medical Center West Hospital ( Site 3868)	Kobe	Hyogo	Japan	653-0013
14	National Hospital Organization Mito Medical Center ( Site 3846)	Higashiibaraki-gun	Ibaraki	Japan	311-3193
15	National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)	Naka-gun	Ibaraki	Japan	319-1113
16	JA Toride Medical Center ( Site 3822)	Toride	Ibaraki	Japan	302-0022
17	National Hospital Organization Kasumigaura Medical Center ( Site 3844)	Tsuchiura	Ibaraki	Japan	300-8585
18	Ishikawa Prefectural Central Hospital ( Site 3915)	Kanazawa	Ishikawa	Japan	920-8530
19	Japan Community Health care Organization Kanazawa Hospital ( Site 3817)	Kanazawa	Ishikawa	Japan	920-8610
20	Komatsu Municipal Hospital ( Site 3892)	Komatsu	Ishikawa	Japan	923-8560
21	Kamei Internal Medicine and Respiratory Clinic ( Site 3904)	Takamatsu	Kagawa	Japan	761-8073
22	Fujisawa City Hospital ( Site 3891)	Fujisawa	Kanagawa	Japan	251-8550
23	Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)	Kawasaki	Kanagawa	Japan	210-0852
24	Yokohama City Minato Red Cross Hospital ( Site 3906)	Yokohama	Kanagawa	Japan	231-8682
25	Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)	Yokohama	Kanagawa	Japan	234-8503
26	Kanagawa Cardiovascular and Respiratory Center ( Site 3908)	Yokohama	Kanagawa	Japan	236-0051
27	Matsusaka City Hospital ( Site 3825)	Matsusaka	Mie	Japan	515-8544
28	Koyama Medical Clinic ( Site 3838)	Matsumoto	Nagano	Japan	390-0872
29	Nagaoka Red Cross Hospital ( Site 3877)	Nagaoka	Niigata	Japan	940-2085
30	National Hospital Organization Minami-Okayama Medical Center ( Site 3901)	Tsukubo-gun	Okayama	Japan	701-0304
31	Kawaguchi Respiratory Clinic ( Site 3890)	Higashiosaka	Osaka	Japan	577-0843
32	Kishiwada City Hospital ( Site 3880)	Kishiwada	Osaka	Japan	596-8501
33	Kindai University Hospital ( Site 3871)	Osakasayama	Osaka	Japan	589-8511
34	Sasaki Naika Clinic ( Site 3872)	Sakai	Osaka	Japan	591-8037
35	National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3900)	Sakai	Osaka	Japan	591-8555
36	Sugiura Clinic ( Site 3806)	Kawaguchi	Saitama	Japan	332-0012
37	National Hospital Organization Matsue Medical Center ( Site 3848)	Matsue	Shimane	Japan	690-8556
38	JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)	Hamamatsu	Shizuoka	Japan	430-8525
39	Hamamatsu Medical Center ( Site 3866)	Hamamatsu	Shizuoka	Japan	432-8580
40	National Hospital Organization Tenryu Hospital ( Site 3823)	Hamamatsu	Shizuoka	Japan	434-8511
41	Tokyo Medical University Hachioji Medical Center ( Site 3911)	Hachioji	Tokyo	Japan	193-0998
42	National Hospital Organization Tokyo National Hospital ( Site 3909)	Kiyose	Tokyo	Japan	204-8585
43	Kiheibashi Otolaryngology ( Site 3828)	Kodaira	Tokyo	Japan	187-0044
44	Shimonoseki City Hospital ( Site 3902)	Shimonoseki	Yamaguchi	Japan	750-8520
45	Akita University Hospital ( Site 3851)	Akita		Japan	010-8543
46	Fukui-ken Saiseikai Hospital ( Site 3874)	Fukui		Japan	918-8503
47	Gifu Prefectural General Medical Center ( Site 3824)	Gifu		Japan	500-8717
48	Tochigi Takao Clinic ( Site 3833)	Kagoshima		Japan	890-0073
49	Nagano Red Cross Hospital ( Site 3859)	Nagano		Japan	380-8582
50	Saiseikai Niigata Hospital ( Site 3831)	Niigata		Japan	950-1104
51	Oita Red Cross Hospital ( Site 3837)	Oita		Japan	870-0033
52	Yamagata Clinic ( Site 3813)	Oita		Japan	870-0921
53	Chibana Clinic ( Site 3809)	Okinawa		Japan	904-2143
54	Ito ENT Clinic ( Site 3816)	Shizuoka		Japan	420-0803
55	Nihonbashi Egawa Clinic ( Site 3805)	Tokyo		Japan	103-0028
56	The Fraternity Memorial Hospital ( Site 3873)	Tokyo		Japan	130-8587
57	Showa University Hospital ( Site 3896)	Tokyo		Japan	142-8666
58	Ebisu Clinic Koukokukai Medical Corporation ( Site 3804)	Tokyo		Japan	150-0013
59	Kono Medical Clinic ( Site 3894)	Tokyo		Japan	157-0072
60	Medical Corporation Kouwakai Kouwa Clinic ( Site 3895)	Tokyo		Japan	170-0003
61	Tokyo Metropolitan Geriatric Hospital ( Site 3905)	Tokyo		Japan	173-0015

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 26, 2018

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT03696108
• Other Study ID Numbers: 7264-038; MK-7264-038; 184154
• First Posted: Oct 4, 2018
• Last Update Posted: Nov 1, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cough

Study Results

Participant Flow

Pre-assignment Detail	A total of 175 participants were originally enrolled in the study. 6 participants at one site were excluded from all analyses, including disposition, due to good clinical practice (GCP) noncompliance at the study site.

Arm/Group Title	Gefapixant 15 mg BID	Gefapixant 45 mg BID
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks	Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Period Title: Overall Study
STARTED	84	85
COMPLETED	80	79
NOT COMPLETED	4	6

Baseline Characteristics

Arm/Group Title	Gefapixant 15 mg BID	Gefapixant 45 mg BID	Total
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks	Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks	Total of all reporting groups
Overall Participants	84	85	169
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.2 (14.1)	57.6 (15.8)	57.9 (15.0)
Sex: Female, Male (Count of Participants)
Female	55 65.5%	51 60%	106 62.7%
Male	29 34.5%	34 40%	63 37.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	84 100%	85 100%	169 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	84 100%	85 100%	169 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced at Least One Adverse Event (AE)
Description	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.
Time Frame	Up to 54 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study treatment.

Arm/Group Title	Gefapixant 15 mg BID	Gefapixant 45 mg
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Measure Participants	84	85
Count of Participants [Participants]	79 94%	82 96.5%

2. Primary Outcome

Title	Number of Participants Who Discontinued Study Drug Due to an AE
Description	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.
Time Frame	Up to 52 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study treatment.

Arm/Group Title	Gefapixant 15 mg BID	Gefapixant 45 mg
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Measure Participants	84	85
Count of Participants [Participants]	6 7.1%	17 20%

3. Secondary Outcome

Title	Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Description	The LCQ is a 19-item cough-specific health-related quality of life (HRQoL) questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period.

Arm/Group Title	Gefapixant 15 mg BID	Gefapixant 45 mg
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Measure Participants	84	85
Least Squares Mean (95% Confidence Interval) [Scores on a Scale]	1.4	0.9

4. Secondary Outcome

Title	Change From Baseline in LCQ Total Score
Description	The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model at weeks 4, 8, 12, 24, 38 and 52 of treatment.
Time Frame	Baseline, up to 52 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period.

Arm/Group Title	Gefapixant 15 mg BID	Gefapixant 45 mg
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Measure Participants	84	85
Week 4	0.9	0.8
Week 8	1.5	1.2
Week 12	1.4	0.9
Week 24	1.6	1.1
Week 38	1.8	1.2
Week 52	2.3	1.5

5. Secondary Outcome

Title	Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score
Description	The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. 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 weeks 4, 8, 12, 24, 38 and 52 of treatment.
Time Frame	Baseline, Up to 52 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period.

Arm/Group Title	Gefapixant 15 mg BID	Gefapixant 45 mg
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Measure Participants	84	85
Week 4	38.1 45.4%	36.5 42.9%
Week 8	43.4 51.7%	43.2 50.8%
Week 12	48.2 57.4%	40.7 47.9%
Week 24	53.7 63.9%	45.7 53.8%
Week 38	56.1 66.8%	44.9 52.8%
Week 52	58.8 70%	46.8 55.1%

Adverse Events

Time Frame	Up to approximately 54 weeks
Adverse Event Reporting Description	The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Arm/Group Title	Gefapixant 15 mg		Gefapixant 45 mg
Arm/Group Description	Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks		Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
All Cause Mortality
	Gefapixant 15 mg		Gefapixant 45 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/85 (0%)
Serious Adverse Events
	Gefapixant 15 mg		Gefapixant 45 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/84 (2.4%)		10/85 (11.8%)
Gastrointestinal disorders
Large intestine polyp	0/84 (0%)	0	1/85 (1.2%)	1
Hepatobiliary disorders
Hepatic function abnormal	0/84 (0%)	0	1/85 (1.2%)	1
Infections and infestations
Bronchitis	1/84 (1.2%)	1	0/85 (0%)	0
Pneumonia	0/84 (0%)	0	3/85 (3.5%)	3
Pneumonia bacterial	1/84 (1.2%)	1	0/85 (0%)	0
Injury, poisoning and procedural complications
Radius fracture	0/84 (0%)	0	1/85 (1.2%)	1
Metabolism and nutrition disorders
Hypophagia	0/84 (0%)	0	1/85 (1.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma	0/84 (0%)	0	1/85 (1.2%)	1
Ovarian germ cell teratoma benign	0/84 (0%)	0	1/85 (1.2%)	1
Nervous system disorders
Embolic cerebral infarction	0/84 (0%)	0	1/85 (1.2%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	2/84 (2.4%)	2	0/85 (0%)	0
Other (Not Including Serious) Adverse Events
	Gefapixant 15 mg		Gefapixant 45 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	73/84 (86.9%)		76/85 (89.4%)
Gastrointestinal disorders
Constipation	6/84 (7.1%)	6	2/85 (2.4%)	2
Diarrhoea	7/84 (8.3%)	7	2/85 (2.4%)	2
Gastrooesophageal reflux disease	6/84 (7.1%)	6	1/85 (1.2%)	1
Paraesthesia oral	1/84 (1.2%)	1	5/85 (5.9%)	5
General disorders
Pyrexia	5/84 (6%)	5	6/85 (7.1%)	7
Infections and infestations
Bronchitis	10/84 (11.9%)	11	3/85 (3.5%)	3
Gastroenteritis	2/84 (2.4%)	3	6/85 (7.1%)	6
Nasopharyngitis	25/84 (29.8%)	60	33/85 (38.8%)	61
Pharyngitis	8/84 (9.5%)	10	4/85 (4.7%)	6
Injury, poisoning and procedural complications
Accidental overdose	5/84 (6%)	5	3/85 (3.5%)	3
Nervous system disorders
Ageusia	0/84 (0%)	0	5/85 (5.9%)	5
Dysgeusia	14/84 (16.7%)	17	40/85 (47.1%)	40
Headache	9/84 (10.7%)	11	3/85 (3.5%)	3
Hypogeusia	9/84 (10.7%)	9	14/85 (16.5%)	14
Taste disorder	6/84 (7.1%)	6	10/85 (11.8%)	10
Psychiatric disorders
Insomnia	1/84 (1.2%)	1	5/85 (5.9%)	5
Respiratory, thoracic and mediastinal disorders
Asthma	10/84 (11.9%)	15	6/85 (7.1%)	9
Cough	19/84 (22.6%)	34	11/85 (12.9%)	22

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.