Trial Outcomes & Findings for Evaluation of S-600918 in Adults With Refractory Chronic Cough (NCT NCT04110054)
NCT ID: NCT04110054
Last Updated: 2024-03-27
Results Overview
Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour in 24 hours at each visit with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the log-transformed coughs per hour in 24 hours at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
COMPLETED
PHASE2
406 participants
Baseline to Week 4
2024-03-27
Participant Flow
Participant milestones
| Measure |
S-600918 50 mg
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
103
|
100
|
102
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
100
|
103
|
100
|
102
|
|
Overall Study
COMPLETED
|
100
|
99
|
92
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
8
|
3
|
Reasons for withdrawal
| Measure |
S-600918 50 mg
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Overall Study
COVID-19 reason other than AE
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
4
|
3
|
Baseline Characteristics
Evaluation of S-600918 in Adults With Refractory Chronic Cough
Baseline characteristics by cohort
| Measure |
S-600918 50 mg
n=100 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=102 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=96 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=102 Participants
Participants received placebo tablets orally once daily for 28 days
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
295 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
385 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
288 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Average Coughs per Hour in 24 Hours
|
30.40 number of coughs
STANDARD_DEVIATION 22.92 • n=5 Participants
|
40.95 number of coughs
STANDARD_DEVIATION 64.68 • n=7 Participants
|
36.21 number of coughs
STANDARD_DEVIATION 37.91 • n=5 Participants
|
33.85 number of coughs
STANDARD_DEVIATION 34.60 • n=4 Participants
|
35.36 number of coughs
STANDARD_DEVIATION 43.00 • n=21 Participants
|
|
Weekly Severity of Cough
|
74.8 score on a scale
STANDARD_DEVIATION 14.0 • n=5 Participants
|
73.6 score on a scale
STANDARD_DEVIATION 13.8 • n=7 Participants
|
72.6 score on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
71.6 score on a scale
STANDARD_DEVIATION 14.5 • n=4 Participants
|
73.1 score on a scale
STANDARD_DEVIATION 14.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour in 24 hours at each visit with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the log-transformed coughs per hour in 24 hours at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
Outcome measures
| Measure |
S-600918 50 mg
n=92 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=89 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=87 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=95 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment
|
-55.16 percentage change
Interval -62.8 to -45.94
|
-61.08 percentage change
Interval -67.71 to -53.08
|
-65.32 percentage change
Interval -71.37 to -57.99
|
-60.38 percentage change
Interval -67.07 to -52.32
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The number of coughs per hour for 24 hours was measured using a cough monitor.
Outcome measures
| Measure |
S-600918 50 mg
n=92 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=89 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=87 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=95 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment
≥ 50% Reduction
|
38 Participants
|
46 Participants
|
50 Participants
|
49 Participants
|
|
Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment
≥ 30% Reduction
|
55 Participants
|
66 Participants
|
66 Participants
|
61 Participants
|
|
Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment
≥ 70% Reduction
|
24 Participants
|
26 Participants
|
31 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure at the specified timeframe.
Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour while awake at each visit with treatment, week, and treatment-by-week as fixed effect, participants as random effect, and region and the log-transformed coughs per hour while awake at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
Outcome measures
| Measure |
S-600918 50 mg
n=92 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=89 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=87 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=95 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Percent Change in Number of Coughs Per Hour While Awake Following 4 Weeks of Study Treatment
|
-55.77 percentage change
Interval -63.61 to -46.25
|
-61.75 percentage change
Interval -68.52 to -53.52
|
-66.33 percentage change
Interval -72.43 to -58.89
|
-60.31 percentage change
Interval -62.27 to -51.87
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
The number of coughs per hour while awake was measured using a cough monitor.
Outcome measures
| Measure |
S-600918 50 mg
n=92 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=89 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=87 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=95 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment
≥ 30% Reduction
|
55 Participants
|
67 Participants
|
67 Participants
|
61 Participants
|
|
Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment
≥ 50% Reduction
|
41 Participants
|
48 Participants
|
51 Participants
|
46 Participants
|
|
Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment
≥ 70% Reduction
|
22 Participants
|
26 Participants
|
29 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour while asleep at each visit with treatment, week, and treatment-by-week as fixed effect, participants as random effect, and region and the log-transformed coughs per hour while asleep at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
Outcome measures
| Measure |
S-600918 50 mg
n=92 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=87 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=86 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=93 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Percent Change in Number of Coughs Per Hour While Asleep Following 4 Weeks of Study Treatment
|
-54.43 percentage change
Interval -66.61 to -37.8
|
-53.17 percentage change
Interval -65.89 to -35.73
|
-65.48 percentage change
Interval -74.96 to -52.41
|
-52.73 percentage change
Interval -65.3 to -35.61
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Cough severity was assessed by the participant by a visual analog scale with numbers from 0 to 100. Results are presented as change from baseline. Reported change is based on a mixed model for the change in weekly cough severity score after 4 weeks of treatment with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the severity score at baseline as covariates. Higher scores indicated higher cough severity.
Outcome measures
| Measure |
S-600918 50 mg
n=93 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=92 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=91 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=93 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Change From Baseline in Weekly Cough Severity Following 4 Weeks of Study Treatment
|
-19.99 score on a scale
Interval -24.47 to -15.51
|
-22.95 score on a scale
Interval -27.42 to -18.47
|
-28.29 score on a scale
Interval -32.86 to -23.72
|
-21.74 score on a scale
Interval -26.2 to -17.27
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the participant responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21. Higher score indicates a better quality of life. Results are presented as change from baseline. Reported change is based on a mixed model for the change in LCQ Total Score after 4 weeks of treatment with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the LCQ Score of corresponding domain at baseline as covariates.
Outcome measures
| Measure |
S-600918 50 mg
n=86 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=82 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=78 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=82 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score
|
2.80 score on a scale
Interval 2.17 to 3.43
|
3.10 score on a scale
Interval 2.46 to 3.75
|
3.86 score on a scale
Interval 3.19 to 4.53
|
3.17 score on a scale
Interval 2.52 to 3.82
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the participant responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 2. A higher score indicates a better quality of life.
Outcome measures
| Measure |
S-600918 50 mg
n=86 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=82 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=78 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=82 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Number of Responders Defined as Participants With an Increase in LCQ of ≥ 1.3 Points
|
53 Participants
|
56 Participants
|
60 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe for this specific outcome measure.
The ICIQ-SF is a questionnaire used to evaluate the frequency, severity, and impact of urinary incontinence on the quality of life. The questionnaire includes 3 items with responses measured on Likert scales, and 1 item that is measured via a qualitative response. The 3 nominal responses are summed to give the ICIQ score (this total ICIQ-SF score can range from 0 to 21), where a higher score indicates more severe symptoms. The 1 item remaining that is measured via qualitative response is not given a score; rather, the participant selects 1 description out of 8 possible descriptions of this item.
Outcome measures
| Measure |
S-600918 50 mg
n=99 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=101 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=96 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=102 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Baseline, Female With Symptoms
|
9.9 score on a scale
Standard Deviation 5.0
|
8.8 score on a scale
Standard Deviation 5.2
|
9.2 score on a scale
Standard Deviation 4.6
|
8.6 score on a scale
Standard Deviation 4.2
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Change at Week 4 - Female With Symptoms
|
-2.2 score on a scale
Standard Deviation 3.9
|
-1.2 score on a scale
Standard Deviation 3.4
|
-1.6 score on a scale
Standard Deviation 3.8
|
-1.2 score on a scale
Standard Deviation 3.3
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Baseline, Female Without Symptoms
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Change at Week 4 - Female Without Symptoms
|
0.9 score on a scale
Standard Deviation 2.2
|
0.1 score on a scale
Standard Deviation 0.4
|
0.5 score on a scale
Standard Deviation 1.3
|
0.3 score on a scale
Standard Deviation 1.1
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Baseline, Male With Symptoms
|
9.5 score on a scale
Standard Deviation 5.3
|
5.0 score on a scale
Standard Deviation 2.3
|
6.7 score on a scale
Standard Deviation 4.0
|
5.0 score on a scale
Standard Deviation 2.2
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Change at Week 4 - Male With Symptoms
|
-2.0 score on a scale
Standard Deviation 8.3
|
-0.7 score on a scale
Standard Deviation 2.7
|
-1.0 score on a scale
Standard Deviation 2.3
|
-0.9 score on a scale
Standard Deviation 2.2
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Baseline, Male Without Symptoms
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Change at Week 4 - Male Without Symptoms
|
0.8 score on a scale
Standard Deviation 2.4
|
1.3 score on a scale
Standard Deviation 3.2
|
0.5 score on a scale
Standard Deviation 1.4
|
0.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
The SF-36 is a 36-item questionnaire to assesses a participant's health status using 8 health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The mental component reports the average of all the emotionally relevant items and the physical component reports the average of all the physically relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 indicates no disability. Median change can range from -100 to 100. A positive median change indicates an improved outcome.
Outcome measures
| Measure |
S-600918 50 mg
n=99 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=101 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=96 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=102 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Change From Baseline in Short Form (36) Health Survey (SF-36)
Baseline - Physical Component Score
|
38.4 score on a scale
Standard Deviation 6.3
|
38.6 score on a scale
Standard Deviation 5.7
|
38.1 score on a scale
Standard Deviation 5.6
|
37.8 score on a scale
Standard Deviation 5.5
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36)
Change at Week 4 - Physical Component Score
|
-0.3 score on a scale
Standard Deviation 5.0
|
-0.9 score on a scale
Standard Deviation 4.5
|
-0.9 score on a scale
Standard Deviation 4.6
|
-1.3 score on a scale
Standard Deviation 5.0
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36)
Baseline - Mental Component Score
|
46.1 score on a scale
Standard Deviation 10.3
|
47.1 score on a scale
Standard Deviation 9.0
|
47.5 score on a scale
Standard Deviation 8.7
|
47.2 score on a scale
Standard Deviation 9.2
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36)
Change at Week 4 - Mental Component Score
|
2.2 score on a scale
Standard Deviation 5.9
|
1.9 score on a scale
Standard Deviation 6.0
|
2.6 score on a scale
Standard Deviation 6.0
|
3.3 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
The PGIC is a patient-reported measure of overall health status and consists of 1 item adapted from the Clinical Global Impressions scale. The participant selects 1 description out of 7 possible descriptions of this item. The descriptions are numbered from 1 through 7, where lower numbers indicate better quality of life. Participants were considered responders if they reported "Very much improved", "Much improved", or "Minimally improved" from baseline on the PGIC assessment.
Outcome measures
| Measure |
S-600918 50 mg
n=100 Participants
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=102 Participants
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=96 Participants
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=102 Participants
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Number of Responders as Assessed by Patient Global Impression of Change (PGIC)
|
57 Participants
|
72 Participants
|
79 Participants
|
65 Participants
|
Adverse Events
S-600918 50 mg
S-600918 150 mg
S-600918 300 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
S-600918 50 mg
n=101 participants at risk
Participants received 50 mg S-600918 tablets orally once daily for 28 days
|
S-600918 150 mg
n=103 participants at risk
Participants received 150 mg S-600918 tablets orally once daily for 28 days
|
S-600918 300 mg
n=100 participants at risk
Participants received 300 mg S-600918 tablets orally once daily for 28 days
|
Placebo
n=102 participants at risk
Participants received placebo tablets orally once daily for 28 days
|
|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
2.0%
2/101 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
11.7%
12/103 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
27.0%
27/100 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
2.9%
3/102 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.0%
3/101 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
2/103 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.0%
1/100 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
6.9%
7/102 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/101 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
6.0%
6/100 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/102 • Up to 28 days
Safety population included all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER