Trial Outcomes & Findings for Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery (NCT NCT02540265)
NCT ID: NCT02540265
Last Updated: 2017-06-14
Results Overview
Number of subjects reporting treatment emergent adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Through Day 30 Follow-up
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
N1539 30mg
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
19
|
|
Overall Study
Treatment Completion
|
20
|
19
|
18
|
|
Overall Study
COMPLETED
|
20
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
N1539 30mg
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
Baseline characteristics by cohort
| Measure |
N1539 30mg
n=20 Participants
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
n=20 Participants
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
n=19 Participants
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 12.66 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 16.67 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 14.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
Baseline Pain Intensity (0-10 NPRS)
|
7.7 units on a scale
STANDARD_DEVIATION 2.00 • n=5 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.90 • n=7 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 2.24 • n=5 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 2.02 • n=4 Participants
|
PRIMARY outcome
Timeframe: Through Day 30 Follow-upPopulation: All subjects treated with ≥1 dose of study medication (Safety analysis set)
Number of subjects reporting treatment emergent adverse events
Outcome measures
| Measure |
N1539 30mg
n=20 Participants
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
n=20 Participants
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
n=19 Participants
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Number of Subjects With Adverse Events
|
12 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 48 HoursPopulation: All subjects treated with ≥1 dose of study medication and who had baseline PI and at least one post baseline PI (mITT analysis set; efficacy analysis set)
Effect size was estimated based on SPID48 derived using 2-hour windowed last observation carried forward (W2LOCF) method and an analysis of covariance (ANCOVA) model that included treatment and baseline PI score.
Outcome measures
| Measure |
N1539 30mg
n=20 Participants
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
n=20 Participants
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
n=19 Participants
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
|
-9241.9 units on a scale
Standard Error 1411.74
|
-8350.6 units on a scale
Standard Error 1413.30
|
-1991.3 units on a scale
Standard Error 1448.20
|
SECONDARY outcome
Timeframe: 48 HoursPopulation: mITT analysis set
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.
Outcome measures
| Measure |
N1539 30mg
n=20 Participants
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
n=20 Participants
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
n=19 Participants
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
|
-9241.9 units on a scale
Standard Error 1411.74
|
-8350.6 units on a scale
Standard Error 1413.30
|
-1991.3 units on a scale
Standard Error 1448.20
|
SECONDARY outcome
Timeframe: 48 HoursPopulation: mITT analysis set
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.
Outcome measures
| Measure |
N1539 30mg
n=20 Participants
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
n=20 Participants
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
n=19 Participants
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Summed Pain Intensity Difference (SPID) at Other Intervals
SPID6 (Hour 0-6)
|
-793.87 units on a scale
Standard Error 172.45
|
-663.17 units on a scale
Standard Error 172.64
|
146.22 units on a scale
Standard Error 176.91
|
|
Summed Pain Intensity Difference (SPID) at Other Intervals
SPID12 (Hour 0-12)
|
-1655.1 units on a scale
Standard Error 338.78
|
-1334.9 units on a scale
Standard Error 339.15
|
319.67 units on a scale
Standard Error 347.53
|
|
Summed Pain Intensity Difference (SPID) at Other Intervals
SPID24 (Hour 0-24)
|
-3024.0 units on a scale
Standard Error 644.63
|
-2793.3 units on a scale
Standard Error 645.34
|
276.46 units on a scale
Standard Error 661.28
|
|
Summed Pain Intensity Difference (SPID) at Other Intervals
SPID12-24 (Hour 12-24)
|
-1368.9 units on a scale
Standard Error 343.34
|
-1458.4 units on a scale
Standard Error 343.72
|
-43.21 units on a scale
Standard Error 352.21
|
|
Summed Pain Intensity Difference (SPID) at Other Intervals
SPID12-48 (Hour 12-48)
|
-7586.8 units on a scale
Standard Error 1121.12
|
-7015.7 units on a scale
Standard Error 1122.35
|
-2311.0 units on a scale
Standard Error 1150.07
|
|
Summed Pain Intensity Difference (SPID) at Other Intervals
SPID24-48 (Hour 24-48)
|
-6217.9 units on a scale
Standard Error 817.22
|
-5557.3 units on a scale
Standard Error 818.12
|
-2267.8 units on a scale
Standard Error 838.33
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: mITT analysis set
Outcome measures
| Measure |
N1539 30mg
n=20 Participants
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
n=20 Participants
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
n=19 Participants
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Number of Subjects With Use of Rescue Medication (Oral Opioids)
Hour 0-24
|
20 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Use of Rescue Medication (Oral Opioids)
Hour 24-48
|
11 Participants
|
10 Participants
|
14 Participants
|
|
Number of Subjects With Use of Rescue Medication (Oral Opioids)
Hour 0-48
|
20 Participants
|
18 Participants
|
19 Participants
|
Adverse Events
N1539 30mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
N1539 60mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
IV Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N1539 30mg
n=20 participants at risk
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539
|
N1539 60mg
n=20 participants at risk
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539
|
IV Placebo
n=19 participants at risk
IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Number of events 9 • 30 days
|
20.0%
4/20 • Number of events 5 • 30 days
|
21.1%
4/19 • Number of events 8 • 30 days
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • 30 days
|
15.0%
3/20 • Number of events 5 • 30 days
|
21.1%
4/19 • Number of events 8 • 30 days
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Number of events 6 • 30 days
|
10.0%
2/20 • Number of events 2 • 30 days
|
5.3%
1/19 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 2 • 30 days
|
10.0%
2/20 • Number of events 4 • 30 days
|
0.00%
0/19 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 4 • 30 days
|
0.00%
0/20 • 30 days
|
5.3%
1/19 • Number of events 2 • 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • 30 days
|
5.0%
1/20 • Number of events 1 • 30 days
|
10.5%
2/19 • Number of events 2 • 30 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
2/20 • Number of events 2 • 30 days
|
0.00%
0/20 • 30 days
|
5.3%
1/19 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • 30 days
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/19 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
2/20 • Number of events 2 • 30 days
|
0.00%
0/20 • 30 days
|
0.00%
0/19 • 30 days
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Number of events 1 • 30 days
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/19 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER