Trial Outcomes & Findings for A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee (NCT NCT01554579)
NCT ID: NCT01554579
Last Updated: 2019-06-27
Results Overview
Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.
COMPLETED
PHASE2
171 participants
2 Weeks
2019-06-27
Participant Flow
Participant milestones
| Measure |
Sugar Pill
Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
|
Gefapixant
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
|
Overall Study
COMPLETED
|
76
|
58
|
|
Overall Study
NOT COMPLETED
|
10
|
27
|
Reasons for withdrawal
| Measure |
Sugar Pill
Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
|
Gefapixant
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
25
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=86 Participants
Sugar Pill: Placebo
|
Gefapixant
n=85 Participants
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
124 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=93 Participants
|
85 participants
n=4 Participants
|
171 participants
n=27 Participants
|
|
Numeric Pain Rating Scale (NPRS)
|
6.7 units on a scale
n=93 Participants
|
6.8 units on a scale
n=4 Participants
|
6.75 units on a scale
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.
Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.
Outcome measures
| Measure |
Sugar Pill
n=82 Participants
Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
|
Gefapixant
n=74 Participants
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
|---|---|---|
|
The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
|
5.3 units on a scale
Interval 0.0 to 10.0
|
4.9 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.
This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system \[IVRS\]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.
Outcome measures
| Measure |
Sugar Pill
n=79 Participants
Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
|
Gefapixant
n=71 Participants
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
|---|---|---|
|
WOMAC Scores
|
40.7 units on a scale
Standard Deviation 23.12
|
41.0 units on a scale
Standard Deviation 25.26
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.
The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.
Outcome measures
| Measure |
Sugar Pill
n=80 Participants
Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
|
Gefapixant
n=73 Participants
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
|---|---|---|
|
SF-36
|
3.8 units on a scale
Standard Deviation 2.39
|
4.1 units on a scale
Standard Deviation 2.77
|
Adverse Events
Sugar Pill
Gefapixant
Serious adverse events
| Measure |
Sugar Pill
n=86 participants at risk
Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
|
Gefapixant
n=85 participants at risk
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/85
|
Other adverse events
| Measure |
Sugar Pill
n=86 participants at risk
Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
|
Gefapixant
n=85 participants at risk
Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
|
|---|---|---|
|
Nervous system disorders
Dysgeusia
|
4.7%
4/86 • Number of events 4
|
75.3%
64/85 • Number of events 64
|
|
Nervous system disorders
Ageusia
|
0.00%
0/86
|
14.1%
12/85 • Number of events 12
|
|
Nervous system disorders
headache
|
11.6%
10/86 • Number of events 10
|
10.6%
9/85 • Number of events 9
|
|
Nervous system disorders
hypogeusia
|
0.00%
0/86
|
8.2%
7/85 • Number of events 7
|
|
Nervous system disorders
dizziness
|
3.5%
3/86 • Number of events 3
|
7.1%
6/85 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 60 days prior to the submission of any results, the PI shall submit to SPONSOR any proposed PUBLICATION, which period may be extended for an additional 30 days if requested by SPONSOR. If any Confidential Information should be redacted or patent applications relating to an Invention should be filed prior to PUBLICATION, then PUBLICATION will be delayed until patent application has been filed. Delay of a PUBLICATION shall not exceed 24 months from the date of such notice to the PI.
- Publication restrictions are in place
Restriction type: OTHER