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Trial record 2 of 2 for:    AF-219 IPF

A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502097
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : May 26, 2021
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Idiopathic Pulmonary Fibrosis
Cough
Interventions Drug: Gefapixant
Other: Placebo
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gefapixant>Placebo Pre-Amendment 3 Placebo>Gefapixant Pre-Amendment 3 Gefapixant>Placebo Post-Amendment 3 Placebo>Gefapixant Post-Amendment 3
Hide Arm/Group Description 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 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 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 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 Title: Period 1
Started 4 3 22 22
Completed 4 3 21 22
Not Completed 0 0 1 0
Reason Not Completed
Adverse Event             0             0             1             0
Period Title: Wash Out Period
Started 4 3 21 22
Completed 4 2 20 21
Not Completed 0 1 1 1
Reason Not Completed
Adverse Event             0             1             1             1
Period Title: Period 2
Started 4 2 20 21
Completed 4 2 19 21
Not Completed 0 0 1 0
Reason Not Completed
Adverse Event             0             0             1             0
Arm/Group Title Gefapixant>Placebo Pre-Amendment 3 Placebo>Gefapixant Pre-Amendment 3 Gefapixant>Placebo Post-Amendment 3 Placebo>Gefapixant Post-Amendment 3 Total
Hide Arm/Group Description 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 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 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 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 of all reporting groups
Overall Number of Baseline Participants 4 3 22 22 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 22 participants 22 participants 51 participants
73.0  (5.35) 66.7  (0.53) 69.0  (9.43) 70.0  (5.06) 69.6  (7.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 22 participants 22 participants 51 participants
Female
1
  25.0%
1
  33.3%
3
  13.6%
6
  27.3%
11
  21.6%
Male
3
  75.0%
2
  66.7%
19
  86.4%
16
  72.7%
40
  78.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 22 participants 22 participants 51 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
1
   2.0%
Not Hispanic or Latino
4
 100.0%
3
 100.0%
22
 100.0%
21
  95.5%
50
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 22 participants 22 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
3
 100.0%
22
 100.0%
21
  95.5%
50
  98.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: Coughs/hour
Day 7 -9.1  (2.7) -6.6  (2.7)
Day 14 -6.6  (4.5) -5.8  (4.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.5096
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-10.1 to 5.1
Estimation Comments LS mean difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.8983
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-13.4 to 11.8
Estimation Comments LS mean difference Day 14
2.Primary Outcome
Title Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
Baseline Number Analyzed 39 participants 39 participants
46.2  (43.06) 48.0  (55.17)
Day 7 Number Analyzed 36 participants 37 participants
37.1  (46.52) 41.8  (50.11)
Day 14 Number Analyzed 36 participants 38 participants
39.4  (57.67) 41.9  (44.37)
3.Primary Outcome
Title Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
Day 7 Number Analyzed 36 participants 37 participants
-8.8  (21.81) -6.6  (13.36)
Day 14 Number Analyzed 36 participants 38 participants
-5.9  (36.76) -5.7  (19.63)
4.Primary Outcome
Title Percent Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: Percent change
Day 7 Number Analyzed 36 participants 37 participants
-18.2  (50.06) -14.1  (31.14)
Day 14 Number Analyzed 36 participants 38 participants
-11.9  (60.00) 6.6  (58.83)
5.Secondary Outcome
Title MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 1)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 19 20
Least Squares Mean (Standard Error)
Unit of Measure: Coughs/hour
Day 7 -15.6  (4.0) -11.9  (3.7)
Day 14 -14.9  (6.6) -13.1  (6.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.5005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-14.6 to 7.2
Estimation Comments LS means difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.8382
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-19.8 to 16.1
Estimation Comments LS means difference Day 14
6.Secondary Outcome
Title MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 2)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 20 19
Least Squares Mean (Standard Error)
Unit of Measure: Coughs/hour
Day 7 -2.7  (3.7) -1.3  (3.8)
Day 14 1.7  (6.2) 1.5  (6.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.8008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-11.9 to 9.2
Estimation Comments LS means difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.9805
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-17.6 to 18.0
Estimation Comments LS means difference Day 14
7.Secondary Outcome
Title Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Day 7 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 36 37
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7: >= 70% reduction
1
   2.8%
1
   2.7%
Day 7: >= 50% reduction
8
  22.2%
5
  13.5%
Day 7: >= 30% reduction
19
  52.8%
11
  29.7%
Day 7: >= 20% reduction
22
  61.1%
13
  35.1%
8.Secondary Outcome
Title Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 36 38
Measure Type: Count of Participants
Unit of Measure: Participants
Day 14: >= 70% reduction
3
   8.3%
1
   2.6%
Day 14: >= 50% reduction
11
  30.6%
3
   7.9%
Day 14: >= 30% reduction
18
  50.0%
10
  26.3%
Day 14: >= 20% reduction
19
  52.8%
15
  39.5%
9.Secondary Outcome
Title MMRM Analysis of Change From Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: Coughs/hour
Day 7 -7.1  (1.7) -4.7  (1.7)
Day 14 -2.5  (3.9) -4.0  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.3279
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-7.1 to 2.4
Estimation Comments LS means difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.7772
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-9.2 to 12.3
Estimation Comments LS means difference Day 14
10.Secondary Outcome
Title MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 1)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 19 20
Least Squares Mean (Standard Error)
Unit of Measure: Coughs/hour
Day 7 -11.8  (2.5) -8.5  (2.3)
Day 14 -9.1  (5.6) -10.1  (5.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.3493
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-10.1 to 3.6
Estimation Comments LS means difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.8952
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-14.3 to 16.3
Estimation Comments LS means difference Day 14
11.Secondary Outcome
Title MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 2)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 20 19
Least Squares Mean (Standard Error)
Unit of Measure: Coughs/hour
Day 7 -2.4  (2.3) -0.9  (2.4)
Day 14 4.1  (5.3) 2.1  (5.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.6597
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-8.1 to 5.2
Estimation Comments LS means difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.7880
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-13.1 to 17.2
Estimation Comments LS means difference Day 14
12.Secondary Outcome
Title 24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Hide Description 24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
Baseline Number Analyzed 39 participants 39 participants
33.6  (33.39) 35.5  (39.99)
Day 7 Number Analyzed 36 participants 37 participants
26.4  (33.46) 30.5  (39.09)
Day 14 Number Analyzed 36 participants 38 participants
30.6  (47.27) 31.2  (34.19)
13.Secondary Outcome
Title Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
Day 7 Number Analyzed 36 participants 37 participants
-6.8  (13.76) -4.5  (7.78)
Day 14 Number Analyzed 36 participants 38 participants
-2.0  (30.47) -4.0  (16.79)
14.Secondary Outcome
Title Percent Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Percent change
Day 7 Number Analyzed 36 participants 37 participants
-20.4  (49.10) -14.6  (28.97)
Day 14 Number Analyzed 36 participants 38 participants
-9.4  (59.22) -9.7  (64.24)
15.Secondary Outcome
Title MMRM Analysis of Change From Baseline in Sleep Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 38 38
Least Squares Mean (Standard Error)
Unit of Measure: Coughs/hour
Day 7 -1.8  (1.3) 0.8  (1.3)
Day 14 3.3  (3.4) 0.6  (3.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.1856
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-6.3 to 1.3
Estimation Comments LS mean difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.5658
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.6 to 12.1
Estimation Comments LS mean difference Day 14
16.Secondary Outcome
Title MMRM Analysis of Change From Baseline in Cough Visual Analog Scale (VAS) (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 40
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Day 7 -16.3  (3.3) -8.2  (3.2)
Day 14 -14.3  (4.0) -8.5  (4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.0847
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-17.2 to 1.1
Estimation Comments LS mean difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.3083
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.8
Confidence Interval (2-Sided) 95%
-17.0 to 5.4
Estimation Comments LS mean difference Day 14
17.Secondary Outcome
Title MMRM Analysis of Change From Baseline in Cough Quality of Life Questionnaire (CQLQ) (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Day 7 -2.3  (1.2) -0.3  (1.2)
Day 14 0.2  (1.2) 0.3  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.2290
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-5.3 to 1.3
Estimation Comments LS mean difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.9794
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-3.5 to 3.4
Estimation Comments LS mean difference Day 14
18.Secondary Outcome
Title MMRM Analysis of Change From Baseline in Total Daily Cough Severity Diary (CSD) Score (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Week 1, and Week 2 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Week 1 Number Analyzed 36 participants 32 participants
-1.4  (0.2) -0.4  (0.2)
Week 2 Number Analyzed 36 participants 31 participants
-1.7  (0.2) -0.7  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.5 to -0.4
Estimation Comments LS mean difference Week 1
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.7 to -0.3
Estimation Comments LS mean difference Week 2
19.Secondary Outcome
Title MMRM Analysis of Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Day 7 Number Analyzed 40 participants 40 participants
-3.9  (1.9) -1.0  (1.9)
Day 14 Number Analyzed 39 participants 39 participants
-2.4  (1.9) 1.6  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.2938
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-8.2 to 2.5
Estimation Comments LS mean difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.
Statistical Test of Hypothesis P-Value 0.1319
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.0
Confidence Interval (2-Sided) 95%
-9.2 to 1.2
Estimation Comments LS mean difference Day 14
20.Secondary Outcome
Title MMRM Analysis of Change From Baseline in Cough Borg CR10 Scale Score (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Day 7 Number Analyzed 40 participants 40 participants
-0.5  (0.3) 0.1  (0.3)
Day 14 Number Analyzed 39 participants 39 participants
-0.1  (0.4) 0.3  (0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2175
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.5 to 0.4
Estimation Comments LS mean difference Day 7
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gefapixant, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5312
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.4 to 0.7
Estimation Comments LS mean difference Day 14
21.Secondary Outcome
Title Percentage of Participants With Borg CR10 Perception of Breathless Value ≥5 (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: Percent of Participants
Day 7 41.67 43.75
Day 14 50.00 43.75
22.Secondary Outcome
Title Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined)
Hide Description 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".
Time Frame Day 7 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Participants
Very much improved 3 1
Much improved 14 5
Minimally improved 12 10
No change 7 18
Minimally worse 2 4
Much worse 0 1
Very much worse 1 1
23.Secondary Outcome
Title Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined)
Hide Description 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".
Time Frame Day 15 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: Participants
Very much improved 5 4
Much improved 16 8
Minimally improved 8 5
No change 5 16
Minimally worse 4 3
Much worse 1 2
Very much worse 0 0
24.Secondary Outcome
Title Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined)
Hide Description 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".
Time Frame Day 15 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: Participants
Very much improved 7 3
Much improved 11 4
Minimally improved 13 6
No change 4 18
Minimally worse 2 5
Much worse 2 1
Very much worse 0 0
25.Secondary Outcome
Title Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least Six Months
Hide Description 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."
Time Frame After last treatment, up to Day 15 (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: Participants
Extremely unlikely 2 1
Unlikely 4 2
Neither 5 4
Likely 8 12
Extremely likely 21 19
26.Secondary Outcome
Title Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least One Year
Hide Description 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."
Time Frame After last treatment, up to Day 15 (Period 1 and Period 2)
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Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: Participants
Extremely unlikely 3 1
Unlikely 3 2
Neither 5 4
Likely 11 13
Extremely likely 18 18
27.Other Pre-specified Outcome
Title Pre-dose Baseline of Awake Objective Cough Frequency
Hide Description 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.
Time Frame Baseline (Day 0) (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 38
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
Period 1 Number Analyzed 19 participants 20 participants
50.2  (29.50) 56.1  (71.68)
Period 2 Number Analyzed 20 participants 19 participants
42.5  (53.42) 39.4  (29.19)
28.Other Pre-specified Outcome
Title Pre-dose Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined)
Hide Description 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).
Time Frame Baseline (Day 0) (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
33.6  (33.39) 35.5  (39.99)
29.Other Pre-specified Outcome
Title Pre-dose Baseline of 24-hour Objective Cough Frequency (Period 1)
Hide Description 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).
Time Frame Baseline (Day 0) (Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
36.1  (22.18) 42.5  (51.52)
30.Other Pre-specified Outcome
Title Pre-dose Baseline of 24-hour Objective Cough Frequency (Period 2)
Hide Description 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).
Time Frame Baseline (Day 0) (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
31.1  (41.84) 28.1  (21.52)
31.Other Pre-specified Outcome
Title Pre-dose Baseline Sleep Cough Frequency
Hide Description 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).
Time Frame Baseline (Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: Coughs/hour
8.1  (20.83) 8.5  (21.26)
32.Other Pre-specified Outcome
Title Pre-dose Baseline Cough VAS (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0) (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: Score on a scale
56.0  (24.03) 53.9  (22.80)
33.Other Pre-specified Outcome
Title Pre-dose Baseline Cough CQLQ (Periods 1 & 2 Combined)
Hide Description 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).
Time Frame Baseline (Day 0) (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Score on a scale
56.5  (13.26) 56.8  (11.25)
34.Other Pre-specified Outcome
Title Pre-dose Baseline Cough Severity CSD (Periods 1 & 2 Combined)
Hide Description 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.
Time Frame Baseline (Day 0) (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 36 32
Mean (Standard Deviation)
Unit of Measure: Score on a scale
4.5  (1.75) 4.1  (2.04)
35.Other Pre-specified Outcome
Title Pre-dose Baseline of UCSD SOBQ (Periods 1 & 2 Combined)
Hide Description 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).
Time Frame Baseline (Day 0) (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Score on a scale
58.0  (26.06) 57.1  (24.63)
36.Other Pre-specified Outcome
Title Pre-dose Baseline of Cough Borg CR10 Scale Score (Periods 1 & 2 Combined)
Hide Description 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).
Time Frame Baseline (Day 0) (Period 1 and Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gefapixant Placebo
Hide Arm/Group Description:
Gefapixant 50 mg BID for 14 days during 1 of 2 periods
Placebo BID for 14 days during 1 of 2 periods
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Score on a scale
4.4  (3.08) 3.9  (2.56)
Time Frame Up to 63 days (9 weeks)
Adverse Event Reporting Description Analysis population includes all participants who received at least one dose of study drug.
 
Arm/Group Title Placebo Gefapixant 50 mg Gefapixant 150 mg
Hide Arm/Group Description Participants received placebo BID for 14 days Participants received gefapixant 50 mg BID for 10 or 14 days Participants received gefapixant 150 mg BID for 4 days
All-Cause Mortality
Placebo Gefapixant 50 mg Gefapixant 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Gefapixant 50 mg Gefapixant 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/45 (6.67%)      3/47 (6.38%)      1/4 (25.00%)    
Cardiac disorders       
Atrial fibrillations  1  0/45 (0.00%)  0 1/47 (2.13%)  1 0/4 (0.00%)  0
Palpitations  1  0/45 (0.00%)  0 1/47 (2.13%)  1 0/4 (0.00%)  0
General disorders       
Chest pain  1  0/45 (0.00%)  0 1/47 (2.13%)  1 0/4 (0.00%)  0
Infections and infestations       
Bronchitis  1  1/45 (2.22%)  1 1/47 (2.13%)  1 1/4 (25.00%)  1
Pneumonia  1  2/45 (4.44%)  2 0/47 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dysponea  1  0/45 (0.00%)  0 1/47 (2.13%)  1 0/4 (0.00%)  0
Interstitial Lung Disease  1  0/45 (0.00%)  0 1/47 (2.13%)  1 0/4 (0.00%)  0
Respiratory failure  1  0/45 (0.00%)  0 1/47 (2.13%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Gefapixant 50 mg Gefapixant 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/45 (26.67%)      39/47 (82.98%)      3/4 (75.00%)    
Gastrointestinal disorders       
Diarrhoea  1  2/45 (4.44%)  2 3/47 (6.38%)  3 0/4 (0.00%)  0
Hypoaesthesia oral  1  0/45 (0.00%)  0 4/47 (8.51%)  5 0/4 (0.00%)  0
Paraesthesia oral  1  0/45 (0.00%)  0 4/47 (8.51%)  6 0/4 (0.00%)  0
Nausea  1  0/45 (0.00%)  0 5/47 (10.64%)  5 0/4 (0.00%)  0
Infections and infestations       
Respiratory tract infection  1  0/45 (0.00%)  0 0/47 (0.00%)  0 1/4 (25.00%)  1
Upper respiratory tract infection  1  0/45 (0.00%)  0 1/47 (2.13%)  1 1/4 (25.00%)  1
Urinary tract infection  1  1/45 (2.22%)  1 3/47 (6.38%)  3 1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/45 (0.00%)  0 0/47 (0.00%)  0 1/4 (25.00%)  1
Nervous system disorders       
Ageusia  1  0/45 (0.00%)  0 11/47 (23.40%)  14 0/4 (0.00%)  0
Dizziness  1  0/45 (0.00%)  0 4/47 (8.51%)  4 0/4 (0.00%)  0
Dysgeusia  1  1/45 (2.22%)  1 25/47 (53.19%)  28 0/4 (0.00%)  0
Hypogeusia  1  0/45 (0.00%)  0 5/47 (10.64%)  6 0/4 (0.00%)  0
Renal and urinary disorders       
Pollakiuria  1  1/45 (2.22%)  1 4/47 (8.51%)  4 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  6/45 (13.33%)  7 6/47 (12.77%)  7 0/4 (0.00%)  0
Rales  1  2/45 (4.44%)  2 0/47 (0.00%)  0 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No data collected as part of this study will be utilized in any written work, including publications, without the written consent of Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
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Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02502097    
Other Study ID Numbers: 7264-016
AF-219-016 ( Other Identifier: Afferent Pharmaceuticals )
MK-7264-016 ( Other Identifier: Merck Protocol Number )
First Submitted: July 16, 2015
First Posted: July 20, 2015
Results First Submitted: March 22, 2021
Results First Posted: May 26, 2021
Last Update Posted: May 26, 2021