Trial Outcomes & Findings for A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016) (NCT NCT02502097)
NCT ID: NCT02502097
Last Updated: 2021-05-26
Results Overview
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0 (baseline), and after administration of the study drug on Day 7 and Day 14 in Periods 1 and 2. The cough frequency is the coughs/hour over each 24-hour period. Awake objective cough frequency was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the results of the 2-period cross-over study. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.
COMPLETED
PHASE2
51 participants
Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
2021-05-26
Participant Flow
Participant milestones
| Measure |
Gefapixant>Placebo Pre-Amendment 3
Gefapixant 50 mg twice daily (BID) for 10 days, then 150 mg BID for 4 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
|
Placebo>Gefapixant Pre-Amendment 3
Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 10 days, then 150 mg for 4 days in Period 2
|
Gefapixant>Placebo Post-Amendment 3
Gefapixant 50 mg twice daily (BID) for 14 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
|
Placebo>Gefapixant Post-Amendment 3
Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 14 days in Period 2
|
|---|---|---|---|---|
|
Period 1
STARTED
|
4
|
3
|
22
|
22
|
|
Period 1
COMPLETED
|
4
|
3
|
21
|
22
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Wash Out Period
STARTED
|
4
|
3
|
21
|
22
|
|
Wash Out Period
COMPLETED
|
4
|
2
|
20
|
21
|
|
Wash Out Period
NOT COMPLETED
|
0
|
1
|
1
|
1
|
|
Period 2
STARTED
|
4
|
2
|
20
|
21
|
|
Period 2
COMPLETED
|
4
|
2
|
19
|
21
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Gefapixant>Placebo Pre-Amendment 3
Gefapixant 50 mg twice daily (BID) for 10 days, then 150 mg BID for 4 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
|
Placebo>Gefapixant Pre-Amendment 3
Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 10 days, then 150 mg for 4 days in Period 2
|
Gefapixant>Placebo Post-Amendment 3
Gefapixant 50 mg twice daily (BID) for 14 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
|
Placebo>Gefapixant Post-Amendment 3
Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 14 days in Period 2
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
|
Wash Out Period
Adverse Event
|
0
|
1
|
1
|
1
|
|
Period 2
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)
Baseline characteristics by cohort
| Measure |
Gefapixant>Placebo Pre-Amendment 3
n=4 Participants
Gefapixant 50 mg twice daily (BID) for 10 days, then 150 mg BID for 4 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
|
Placebo>Gefapixant Pre-Amendment 3
n=3 Participants
Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 10 days, then 150 mg for 4 days in Period 2
|
Gefapixant>Placebo Post-Amendment 3
n=22 Participants
Gefapixant 50 mg twice daily (BID) for 14 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
|
Placebo>Gefapixant Post-Amendment 3
n=22 Participants
Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 14 days in Period 2
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.0 Years
STANDARD_DEVIATION 5.35 • n=5 Participants
|
66.7 Years
STANDARD_DEVIATION 0.53 • n=7 Participants
|
69.0 Years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
70.0 Years
STANDARD_DEVIATION 5.06 • n=4 Participants
|
69.6 Years
STANDARD_DEVIATION 7.17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Ethnicity (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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 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
|
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)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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)
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0 (baseline), and after administration of the study drug on Day 7 and Day 14 in Periods 1 and 2. The cough frequency is the coughs/hour over each 24-hour period. Awake objective cough frequency was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the results of the 2-period cross-over study. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=39 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
-9.1 Coughs/hour
Standard Error 2.7
|
-6.6 Coughs/hour
Standard Error 2.7
|
|
Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
-6.6 Coughs/hour
Standard Error 4.5
|
-5.8 Coughs/hour
Standard Error 4.4
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0 (baseline), and after administration of the study drug on Day 7 and Day 14 in Periods 1 and 2. The cough frequency is the coughs/hour over each 24-hour period. Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=39 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Baseline
|
46.2 Coughs/hour
Standard Deviation 43.06
|
48.0 Coughs/hour
Standard Deviation 55.17
|
|
Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
37.1 Coughs/hour
Standard Deviation 46.52
|
41.8 Coughs/hour
Standard Deviation 50.11
|
|
Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
39.4 Coughs/hour
Standard Deviation 57.67
|
41.9 Coughs/hour
Standard Deviation 44.37
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0 (baseline), and after administration of the study drug on Day 7 and Day 14 in Periods 1 and 2. The cough frequency is the coughs/hour over each 24-hour period. Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. A negative value indicates a decrease in cough frequency.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=39 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
-8.8 Coughs/hour
Standard Deviation 21.81
|
-6.6 Coughs/hour
Standard Deviation 13.36
|
|
Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
-5.9 Coughs/hour
Standard Deviation 36.76
|
-5.7 Coughs/hour
Standard Deviation 19.63
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Percent change from baseline in awake objective cough frequency (0-6 hours after the morning dose) was reported at each dosing interval. Percent change in awake cough frequency = 100 X (post treatment cough frequency - baseline cough frequency) divided by the baseline cough frequency. A negative value indicates a decrease in cough frequency.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=39 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Percent Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
-18.2 Percent change
Standard Deviation 50.06
|
-14.1 Percent change
Standard Deviation 31.14
|
|
Percent Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
-11.9 Percent change
Standard Deviation 60.00
|
6.6 Percent change
Standard Deviation 58.83
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Change from Baseline in awake cough frequency = post-treatment awake cough frequency - Baseline awake cough frequency. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. Awake objective cough frequency for Period 1 was analyzed for using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=19 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=20 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 1)
Day 7
|
-15.6 Coughs/hour
Standard Error 4.0
|
-11.9 Coughs/hour
Standard Error 3.7
|
|
MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 1)
Day 14
|
-14.9 Coughs/hour
Standard Error 6.6
|
-13.1 Coughs/hour
Standard Error 6.1
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Change from baseline in awake cough frequency = post-treatment awake cough frequency - Baseline awake cough frequency. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the at the end of the dosing period. Awake objective cough frequency for Period 2 was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=20 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=19 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 2)
Day 7
|
-2.7 Coughs/hour
Standard Error 3.7
|
-1.3 Coughs/hour
Standard Error 3.8
|
|
MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 2)
Day 14
|
1.7 Coughs/hour
Standard Error 6.2
|
1.5 Coughs/hour
Standard Error 6.4
|
SECONDARY outcome
Timeframe: Day 7 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. The number of participants that met responder criteria for ≥70%, ≥50%, ≥30%, and ≥20% change (reduction) from baseline levels in 24-hour awake cough frequency was reported (Period 1 and Period 2 combined) at Day 7.
Outcome measures
| Measure |
Gefapixant
n=36 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=37 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined)
Day 7: >= 70% reduction
|
1 Participants
|
1 Participants
|
|
Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined)
Day 7: >= 50% reduction
|
8 Participants
|
5 Participants
|
|
Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined)
Day 7: >= 30% reduction
|
19 Participants
|
11 Participants
|
|
Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined)
Day 7: >= 20% reduction
|
22 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. The number of participants that met responder criteria for ≥70%, ≥50%, ≥30%, and ≥20% change (reduction) from baseline levels in 24-hour awake cough frequency was reported (Period 1 and Period 2 combined) at Day 14.
Outcome measures
| Measure |
Gefapixant
n=36 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined)
Day 14: >= 70% reduction
|
3 Participants
|
1 Participants
|
|
Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined)
Day 14: >= 50% reduction
|
11 Participants
|
3 Participants
|
|
Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined)
Day 14: >= 30% reduction
|
18 Participants
|
10 Participants
|
|
Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined)
Day 14: >= 20% reduction
|
19 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. 24-hour objective cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=39 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
-7.1 Coughs/hour
Standard Error 1.7
|
-4.7 Coughs/hour
Standard Error 1.7
|
|
MMRM Analysis of Change From Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
-2.5 Coughs/hour
Standard Error 3.9
|
-4.0 Coughs/hour
Standard Error 3.8
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. 24-hour objective cough frequency for Period 1 was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=19 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=20 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 1)
Day 7
|
-11.8 Coughs/hour
Standard Error 2.5
|
-8.5 Coughs/hour
Standard Error 2.3
|
|
MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 1)
Day 14
|
-9.1 Coughs/hour
Standard Error 5.6
|
-10.1 Coughs/hour
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. 24-hour objective cough frequency for Period 2 was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=20 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=19 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 2)
Day 7
|
-2.4 Coughs/hour
Standard Error 2.3
|
-0.9 Coughs/hour
Standard Error 2.4
|
|
MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 2)
Day 14
|
4.1 Coughs/hour
Standard Error 5.3
|
2.1 Coughs/hour
Standard Error 5.5
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=39 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Baseline
|
33.6 Coughs/hour
Standard Deviation 33.39
|
35.5 Coughs/hour
Standard Deviation 39.99
|
|
24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
30.6 Coughs/hour
Standard Deviation 47.27
|
31.2 Coughs/hour
Standard Deviation 34.19
|
|
24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
26.4 Coughs/hour
Standard Deviation 33.46
|
30.5 Coughs/hour
Standard Deviation 39.09
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. 24-hour objective cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
-6.8 Coughs/hour
Standard Deviation 13.76
|
-4.5 Coughs/hour
Standard Deviation 7.78
|
|
Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
-2.0 Coughs/hour
Standard Deviation 30.47
|
-4.0 Coughs/hour
Standard Deviation 16.79
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. Percent change in cough frequency = 100 X (post treatment cough frequency - baseline cough frequency) divided by the baseline cough frequency. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency.
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Percent Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
-20.4 Percent change
Standard Deviation 49.10
|
-14.6 Percent change
Standard Deviation 28.97
|
|
Percent Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
-9.4 Percent change
Standard Deviation 59.22
|
-9.7 Percent change
Standard Deviation 64.24
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Sleep Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24-hour sound recordings were collected with a digital recording device. A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Sleep cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=38 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in Sleep Cough Frequency (Periods 1 & 2 Combined)
Day 7
|
-1.8 Coughs/hour
Standard Error 1.3
|
0.8 Coughs/hour
Standard Error 1.3
|
|
MMRM Analysis of Change From Baseline in Sleep Cough Frequency (Periods 1 & 2 Combined)
Day 14
|
3.3 Coughs/hour
Standard Error 3.4
|
0.6 Coughs/hour
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Cough VAS is scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 10mm with 0 (no cough) and 100 (most severe cough). Baseline cough VAS is defined as average of screening and baseline cough VAS. A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Cough VAS was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in Cough Visual Analog Scale (VAS) (Periods 1 & 2 Combined)
Day 7
|
-16.3 Score on a scale
Standard Error 3.3
|
-8.2 Score on a scale
Standard Error 3.2
|
|
MMRM Analysis of Change From Baseline in Cough Visual Analog Scale (VAS) (Periods 1 & 2 Combined)
Day 14
|
-14.3 Score on a scale
Standard Error 4.0
|
-8.5 Score on a scale
Standard Error 4.0
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
CQLQ is a 28-item scale that has 4 possible responses: 1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree. Subjects were instructed to circle only 1 response. The total CQLQ score is the sum of the individual item scores; the lowest possible score is 28 and the highest 112. Low CQLQ scores for both total and the 6 domains indicate less impact of cough on health-related quality of life. A negative result indicates a decrease in cough impact on quality of life. CQLQ was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in Cough Quality of Life Questionnaire (CQLQ) (Periods 1 & 2 Combined)
Day 7
|
-2.3 Score on a scale
Standard Error 1.2
|
-0.3 Score on a scale
Standard Error 1.2
|
|
MMRM Analysis of Change From Baseline in Cough Quality of Life Questionnaire (CQLQ) (Periods 1 & 2 Combined)
Day 14
|
0.2 Score on a scale
Standard Error 1.2
|
0.3 Score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 1, and Week 2 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
The daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and sleep disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). Baseline CSD score = average of CSD scores at screening and baseline. A negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity. CSD was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in Total Daily Cough Severity Diary (CSD) Score (Periods 1 & 2 Combined)
Week 1
|
-1.4 Score on a scale
Standard Error 0.2
|
-0.4 Score on a scale
Standard Error 0.2
|
|
MMRM Analysis of Change From Baseline in Total Daily Cough Severity Diary (CSD) Score (Periods 1 & 2 Combined)
Week 2
|
-1.7 Score on a scale
Standard Error 0.2
|
-0.7 Score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
UCSD SOBQ is a 24-point item scale to assess shortness of breath questionnaire that has a 6-point scale ranging from 0 to 5 (0 = "not at all", to 5 = "maximal or unable to do because of breathlessness". Lowest possible score is 0 and the highest possible score is 120. The higher the score the more out of breath the participant is reporting. A negative value indicates less breathlessness. UCSD SOBQ was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) (Periods 1 & 2 Combined)
Day 7
|
-3.9 Score on a scale
Standard Error 1.9
|
-1.0 Score on a scale
Standard Error 1.9
|
|
MMRM Analysis of Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) (Periods 1 & 2 Combined)
Day 14
|
-2.4 Score on a scale
Standard Error 1.9
|
1.6 Score on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
The Borg 10 scale assesses post-treatment breathlessness during perceived exertion while exercising. The scale ranges from 0 to 10 where 0 = nothing at all, 1 = very weak, 3 = moderate, 5 = strong, 7 = very strong, 10 = extremely strong. The lowest possible score is 0 and the highest possible score is 10. A negative value indicates less breathlessness. Cough Borg CR10 was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
MMRM Analysis of Change From Baseline in Cough Borg CR10 Scale Score (Periods 1 & 2 Combined)
Day 7
|
-0.5 Score on a scale
Standard Error 0.3
|
0.1 Score on a scale
Standard Error 0.3
|
|
MMRM Analysis of Change From Baseline in Cough Borg CR10 Scale Score (Periods 1 & 2 Combined)
Day 14
|
-0.1 Score on a scale
Standard Error 0.4
|
0.3 Score on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who received at least 1 dose of study drug. Two participants that had missing values for Day 14 were excluded.
The Borg 10 scale assesses post-treatment breathlessness during perceived exertion while exercising. The scale ranges from 0 to 10 where 0 = nothing at all, 1 = very weak, 3 = moderate, 5 = strong, 7 = very strong, 10 = extremely strong. The lowest possible score is 0 and the highest possible score is 10. The percentage of participants with Borg CR10 perception of breathless value ≥5 was assessed.
Outcome measures
| Measure |
Gefapixant
n=48 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=48 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Percentage of Participants With Borg CR10 Perception of Breathless Value ≥5 (Periods 1 & 2 Combined)
Day 7
|
41.67 Percent of Participants
|
43.75 Percent of Participants
|
|
Percentage of Participants With Borg CR10 Perception of Breathless Value ≥5 (Periods 1 & 2 Combined)
Day 14
|
50.00 Percent of Participants
|
43.75 Percent of Participants
|
SECONDARY outcome
Timeframe: Day 7 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
PGIC is the participant self-reported overall improvement of cough following administration of study drug. The PGIC has a 7-point rating scale of "very much improved", "much improved", 'minimally improved", "no change", "minimally worse", "much worse" and "very much worse".
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
Minimally improved
|
12 Participants
|
10 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
No change
|
7 Participants
|
18 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
Minimally worse
|
2 Participants
|
4 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
Very much improved
|
3 Participants
|
1 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
Much improved
|
14 Participants
|
5 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
Much worse
|
0 Participants
|
1 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
Very much worse
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 15 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
PGIC is the participant self-reported overall improvement of cough following administration of study drug. The PGIC has a 7-point rating scale of "very much improved", "much improved", 'minimally improved", "no change", "minimally worse", "much worse" and "very much worse".
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
Very much improved
|
5 Participants
|
4 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
Minimally improved
|
8 Participants
|
5 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
No change
|
5 Participants
|
16 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
Minimally worse
|
4 Participants
|
3 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
Much worse
|
1 Participants
|
2 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
Very much worse
|
0 Participants
|
0 Participants
|
|
Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
Much improved
|
16 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 15 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
CGIC is the clinician's-reported overall improvement of participant's cough following administration of study drug. The CGIC has a 7-point rating scale of "very much improved", "much improved", 'minimally improved", "no change", "minimally worse", "much worse" and "very much worse".
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
Very much improved
|
7 Participants
|
3 Participants
|
|
Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
Much improved
|
11 Participants
|
4 Participants
|
|
Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
Minimally improved
|
13 Participants
|
6 Participants
|
|
Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
No change
|
4 Participants
|
18 Participants
|
|
Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
Minimally worse
|
2 Participants
|
5 Participants
|
|
Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
Much worse
|
2 Participants
|
1 Participants
|
|
Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
Very much worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After last treatment, up to Day 15 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
At the end of the treatment period, participants were asked "How likely would you be to take this medication for at least 6 months?" The degree of taste acceptability was measured on a scale of "extremely unlikely", "unlikely", "neither", "likely" and "extremely likely."
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least Six Months
Unlikely
|
4 Participants
|
2 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least Six Months
Extremely unlikely
|
2 Participants
|
1 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least Six Months
Neither
|
5 Participants
|
4 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least Six Months
Likely
|
8 Participants
|
12 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least Six Months
Extremely likely
|
21 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: After last treatment, up to Day 15 (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
At the end of the treatment period, the participant was asked "How likely would you be to take this medication for at least one year?" The degree of taste acceptability was measured on a scale of "extremely unlikely", "unlikely", "neither", "likely" and "extremely likely."
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least One Year
Extremely unlikely
|
3 Participants
|
1 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least One Year
Unlikely
|
3 Participants
|
2 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least One Year
Neither
|
5 Participants
|
4 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least One Year
Likely
|
11 Participants
|
13 Participants
|
|
Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least One Year
Extremely likely
|
18 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period.
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline of Awake Objective Cough Frequency
Period 1
|
50.2 Coughs/hour
Standard Deviation 29.50
|
56.1 Coughs/hour
Standard Deviation 71.68
|
|
Pre-dose Baseline of Awake Objective Cough Frequency
Period 2
|
42.5 Coughs/hour
Standard Deviation 53.42
|
39.4 Coughs/hour
Standard Deviation 29.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. Baseline 24-hour cough frequency in Periods 1 and 2 was evaluated based on the participant's randomized group (gefapixant or placebo).
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=39 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
|
33.6 Coughs/hour
Standard Deviation 33.39
|
35.5 Coughs/hour
Standard Deviation 39.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. Baseline 24-hour cough frequency for Period 1 was evaluated based on the participant's randomized group (gefapixant or placebo).
Outcome measures
| Measure |
Gefapixant
n=19 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=20 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline of 24-hour Objective Cough Frequency (Period 1)
|
36.1 Coughs/hour
Standard Deviation 22.18
|
42.5 Coughs/hour
Standard Deviation 51.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. Baseline 24-hour objective cough frequency for Period 2 was evaluated based on the participant's randomized group (gefapixant or placebo).
Outcome measures
| Measure |
Gefapixant
n=20 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=19 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline of 24-hour Objective Cough Frequency (Period 2)
|
31.1 Coughs/hour
Standard Deviation 41.84
|
28.1 Coughs/hour
Standard Deviation 21.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Sleep Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24-hour sound recordings were collected with a digital recording device. Baseline sleep cough frequency was evaluated based on the participant's randomized group (gefapixant or placebo).
Outcome measures
| Measure |
Gefapixant
n=38 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=38 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline Sleep Cough Frequency
|
8.1 Coughs/hour
Standard Deviation 20.83
|
8.5 Coughs/hour
Standard Deviation 21.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
Cough VAS is scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 10mm with 0 (no cough) and 100 (most severe cough). Baseline cough VAS was defined as average of screening and baseline cough VAS.
Outcome measures
| Measure |
Gefapixant
n=39 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline Cough VAS (Periods 1 & 2 Combined)
|
56.0 Score on a scale
Standard Deviation 24.03
|
53.9 Score on a scale
Standard Deviation 22.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
CQLQ is a 28-item scale that has 4 possible responses: 1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree. Subjects were instructed to circle only 1 response. The total CQLQ score is the sum of the individual item scores; the lowest possible score is 28 and the highest 112. Low CQLQ scores for both total and the 6 domains indicate less impact of cough on health-related quality of life. Baseline cough CQLQ was evaluated based on the participant's randomized group (gefapixant or placebo).
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline Cough CQLQ (Periods 1 & 2 Combined)
|
56.5 Score on a scale
Standard Deviation 13.26
|
56.8 Score on a scale
Standard Deviation 11.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
The daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and sleep disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). Baseline CSD score = average of CSD scores at screening and baseline.
Outcome measures
| Measure |
Gefapixant
n=36 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=32 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline Cough Severity CSD (Periods 1 & 2 Combined)
|
4.5 Score on a scale
Standard Deviation 1.75
|
4.1 Score on a scale
Standard Deviation 2.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
UCSD SOBQ is a 24-point item scale to assess shortness of breath questionnaire that has a 6-point scale ranging from 0 to 5 (0 = "not at all", to 5 = "maximal or unable to do because of breathlessness". Lowest possible score is 0 and the highest possible score is 120. The higher the score the more out of breath the participant is reporting. Baseline of UCSD SOBQ was evaluated based on the participant's randomized group (gefapixant or placebo).
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline of UCSD SOBQ (Periods 1 & 2 Combined)
|
58.0 Score on a scale
Standard Deviation 26.06
|
57.1 Score on a scale
Standard Deviation 24.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) (Period 1 and Period 2)Population: The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis.
The Borg 10 scale assesses post-treatment breathlessness during perceived exertion while exercising. The scale ranges from 0 to 10 where 0 = nothing at all, 1 = very weak, 3 = moderate, 5 = strong, 7 = very strong, 10 = extremely strong. The lowest possible score is 0 and the highest possible score is 10. The baseline of cough Borg CR10 was evaluated based on the participant's randomized group (gefapixant or placebo).
Outcome measures
| Measure |
Gefapixant
n=40 Participants
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
|
Placebo
n=40 Participants
Placebo BID for 14 days during 1 of 2 periods
|
|---|---|---|
|
Pre-dose Baseline of Cough Borg CR10 Scale Score (Periods 1 & 2 Combined)
|
4.4 Score on a scale
Standard Deviation 3.08
|
3.9 Score on a scale
Standard Deviation 2.56
|
Adverse Events
Placebo
Gefapixant 50 mg
Gefapixant 150 mg
Serious adverse events
| Measure |
Placebo
n=45 participants at risk
Participants received placebo BID for 14 days
|
Gefapixant 50 mg
n=47 participants at risk
Participants received gefapixant 50 mg BID for 10 or 14 days
|
Gefapixant 150 mg
n=4 participants at risk
Participants received gefapixant 150 mg BID for 4 days
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillations
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.4%
2/45 • Number of events 2 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/47 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysponea
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=45 participants at risk
Participants received placebo BID for 14 days
|
Gefapixant 50 mg
n=47 participants at risk
Participants received gefapixant 50 mg BID for 10 or 14 days
|
Gefapixant 150 mg
n=4 participants at risk
Participants received gefapixant 150 mg BID for 4 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • Number of events 2 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
6.4%
3/47 • Number of events 3 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
8.5%
4/47 • Number of events 5 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
8.5%
4/47 • Number of events 6 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
10.6%
5/47 • Number of events 5 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/47 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
2.1%
1/47 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
6.4%
3/47 • Number of events 3 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/47 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
23.4%
11/47 • Number of events 14 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
8.5%
4/47 • Number of events 4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
2.2%
1/45 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
53.2%
25/47 • Number of events 28 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/45 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
10.6%
5/47 • Number of events 6 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
2.2%
1/45 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
8.5%
4/47 • Number of events 4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
6/45 • Number of events 7 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
12.8%
6/47 • Number of events 7 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
4.4%
2/45 • Number of events 2 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
0.00%
0/47 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 63 days (9 weeks)
Analysis population includes all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee No data collected as part of this study will be utilized in any written work, including publications, without the written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER