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Evaluation of N1539 Following Bunionectomy Surgery

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ClinicalTrials.gov Identifier: NCT02675907
Recruitment Status : Completed
First Posted : February 5, 2016
Results First Posted : September 29, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Recro Pharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain, Post-operative
Interventions Drug: N1539
Drug: Intravenous Placebo
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Period Title: Treatment Phase (48 Hours Post-Dose 1)
Started 100 101
Completed 95 96
Not Completed 5 5
Reason Not Completed
Lack of Efficacy             4             4
Withdrawal by Subject             1             1
Period Title: Study Overall
Started 100 101
Completed 97 97
Not Completed 3 4
Reason Not Completed
Lack of Efficacy             1             0
Withdrawal by Subject             2             2
Lost to Follow-up             0             2
Arm/Group Title N1539 30 mg IV Placebo Total
Hide Arm/Group Description

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Total of all reporting groups
Overall Number of Baseline Participants 100 101 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
92
  92.0%
92
  91.1%
184
  91.5%
>=65 years
8
   8.0%
9
   8.9%
17
   8.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 101 participants 201 participants
46.7  (12.79) 48.4  (12.17) 47.6  (12.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
Female
84
  84.0%
87
  86.1%
171
  85.1%
Male
16
  16.0%
14
  13.9%
30
  14.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
Hispanic or Latino
28
  28.0%
36
  35.6%
64
  31.8%
Not Hispanic or Latino
72
  72.0%
65
  64.4%
137
  68.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.0%
3
   3.0%
5
   2.5%
Native Hawaiian or Other Pacific Islander
2
   2.0%
2
   2.0%
4
   2.0%
Black or African American
32
  32.0%
26
  25.7%
58
  28.9%
White
61
  61.0%
68
  67.3%
129
  64.2%
More than one race
3
   3.0%
2
   2.0%
5
   2.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 100 participants 101 participants 201 participants
100
 100.0%
101
 100.0%
201
 100.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 100 participants 101 participants 201 participants
26.9  (4.80) 28.3  (4.02) 27.6  (4.46)
Time from End of Surgery to First Dose  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 100 participants 101 participants 201 participants
0.514  (0.2397) 0.485  (0.2001) 0.500  (0.2206)
Baseline Pain Intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 100 participants 101 participants 201 participants
6.7  (1.90) 7.0  (1.82) 6.8  (1.86)
[1]
Measure Description: Pain Intensity was assessed using the 11-point Numeric Pain Rating Scale (NPRS; 0-10) with the baseline assessment being the NPRS score collection prior to the first study dose.
1.Primary Outcome
Title Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
Hide Description 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, and 2 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 value (i.e. more negative) was better.
Time Frame 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6956.0  (521.69) -4829.3  (519.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Summed Pain Intensity Difference (SPID) at Other Intervals
Hide Description 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, and 2 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 value (i.e. more negative) was better.
Time Frame 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
SPID6 (Hour 0-6) -510.78  (66.22) -288.33  (65.95)
SPID12 (Hour 0-12) -957.83  (123.30) -480.15  (122.80)
SPID24 (Hour 0-24) -2071.0  (247.01) -1167.9  (246.00)
SPID12-48 (Hour 12-48) -5998.2  (439.21) -4349.1  (437.42)
SPID24-48 (Hour 24-48) -4885.1  (313.60) -3661.4  (312.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Row 1 (SPID6)
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Row 2 (SPID12)
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Row 3 (SPID24)
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Row 4 (SPID12-48)
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Row 5 (SPID24-48)
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Time to First Dose of Rescue Analgesia
Hide Description Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Time Frame 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Median (95% Confidence Interval)
Unit of Measure: hours
1.99
(1.53 to 4.12)
2.09
(1.15 to 3.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0076
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects Utilizing Rescue Analgesia
Hide Description Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Time Frame 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Measure Type: Count of Participants
Unit of Measure: Participants
Hour 0-24
83
  83.0%
99
  98.0%
Hour 24-48
48
  48.0%
71
  70.3%
Hour 0-48
83
  83.0%
99
  98.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Row 1 (Hour 0-24)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Row 2 (Hour 24-48)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Row 3 (Hour 0-48)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Number of Doses of Rescue Analgesia Utilized Per Subject
Hide Description Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Time Frame 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Least Squares Mean (Standard Error)
Unit of Measure: doses of rescue analgesia
Hour 0-24 3.97  (0.26) 5.06  (0.26)
Hour 24-48 1.63  (0.25) 2.51  (0.25)
Hour 0-48 5.45  (0.46) 7.49  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Row 1 (Hour 0-24)
Method ANCOVA
Comments P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Row 2 (Hour 24-48)
Method ANCOVA
Comments P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Row 3 (Hour 0-48)
Method ANCOVA
Comments P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site
6.Secondary Outcome
Title Time to Perceptible Pain Relief (TTPPR)
Hide Description Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).
Time Frame 12 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Median (95% Confidence Interval)
Unit of Measure: hours
0.52
(0.35 to 0.74)
1.59
(0.48 to 2.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1228
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Time to Meaningful Pain Relief (TTMPR)
Hide Description Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).
Time Frame 12 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Median (95% Confidence Interval)
Unit of Measure: hours
2.16
(1.00 to 12.01)
3.19
(2.39 to 4.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1048
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
8.Secondary Outcome
Title Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6
Hide Description Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.
Time Frame 6 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Measure Type: Count of Participants
Unit of Measure: Participants
32
  32.0%
20
  19.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0451
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24
Hide Description Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.
Time Frame 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Measure Type: Count of Participants
Unit of Measure: Participants
37
  37.0%
21
  20.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6
Hide Description Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.
Time Frame 6 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Measure Type: Count of Participants
Unit of Measure: Participants
16
  16.0%
8
   7.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0781
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
11.Secondary Outcome
Title Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24
Hide Description Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.
Time Frame 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 100 101
Measure Type: Count of Participants
Unit of Measure: Participants
13
  13.0%
5
   5.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0430
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
12.Secondary Outcome
Title Patient Global Assessment (PGA) of Pain Control at Hour 24
Hide Description PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.
Time Frame 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 95 97
Measure Type: Count of Participants
Unit of Measure: Participants
0 - Poor
17
  17.9%
29
  29.9%
1 - Fair
23
  24.2%
26
  26.8%
2 - Good
28
  29.5%
26
  26.8%
3 - Very Good
17
  17.9%
13
  13.4%
4 - Excellent
10
  10.5%
3
   3.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1070
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site
13.Secondary Outcome
Title Patient Global Assessment (PGA) of Pain Control at Hour 48
Hide Description PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.
Time Frame 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description:

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

Overall Number of Participants Analyzed 95 96
Measure Type: Count of Participants
Unit of Measure: Participants
0 - Poor
7
   7.4%
15
  15.6%
1 - Fair
8
   8.4%
18
  18.8%
2 - Good
26
  27.4%
25
  26.0%
3 - Very Good
30
  31.6%
30
  31.3%
4 - Excellent
24
  25.3%
8
   8.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N1539 30 mg, IV Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site
Time Frame AEs collected from time of first dose through last followup (30 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N1539 30 mg IV Placebo
Hide Arm/Group Description

N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.

N1539

IV Placebo every 24 hours for up to 3 doses.

Intravenous Placebo

All-Cause Mortality
N1539 30 mg IV Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      1/101 (0.99%)    
Show Serious Adverse Events Hide Serious Adverse Events
N1539 30 mg IV Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      2/101 (1.98%)    
General disorders     
Sudden death * 1  0/100 (0.00%)  0 1/101 (0.99%)  1
Injury, poisoning and procedural complications     
Fracture * 1  0/100 (0.00%)  0 1/101 (0.99%)  1
1
Term from vocabulary, MedDRA (18.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
N1539 30 mg IV Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/100 (44.00%)      54/101 (53.47%)    
Gastrointestinal disorders     
Nausea * 1  20/100 (20.00%)  30 26/101 (25.74%)  31
Constipation * 1  4/100 (4.00%)  4 5/101 (4.95%)  5
Diarrhoea * 1  2/100 (2.00%)  2 0/101 (0.00%)  0
Vomiting * 1  3/100 (3.00%)  3 9/101 (8.91%)  11
General disorders     
Injection site erythema * 1  0/100 (0.00%)  0 2/101 (1.98%)  2
Injection site pain * 1  1/100 (1.00%)  1 2/101 (1.98%)  2
Oedema peripheral * 1  2/100 (2.00%)  2 0/101 (0.00%)  0
Infections and infestations     
Cellulitis * 1  2/100 (2.00%)  2 0/101 (0.00%)  0
Incision site cellulitis * 1  0/100 (0.00%)  0 2/101 (1.98%)  2
Wound infection * 1  0/100 (0.00%)  0 2/101 (1.98%)  2
Injury, poisoning and procedural complications     
Skin abrasion * 1  2/100 (2.00%)  2 2/101 (1.98%)  3
Investigations     
Alanine aminotransferase increased * 1  0/100 (0.00%)  0 3/101 (2.97%)  3
Aspartate aminotransferase increased * 1  0/100 (0.00%)  0 2/101 (1.98%)  2
Blood alkaline phosphatase increased * 1  0/100 (0.00%)  0 2/101 (1.98%)  2
Metabolism and nutrition disorders     
Decreased appetite * 1  2/100 (2.00%)  2 7/101 (6.93%)  8
Nervous system disorders     
Dizziness * 1  3/100 (3.00%)  3 4/101 (3.96%)  4
Headache * 1  8/100 (8.00%)  8 12/101 (11.88%)  14
Somnolence * 1  3/100 (3.00%)  3 2/101 (1.98%)  2
Psychiatric disorders     
Insomnia * 1  0/100 (0.00%)  0 2/101 (1.98%)  2
Renal and urinary disorders     
Pollakiuria * 1  1/100 (1.00%)  1 2/101 (1.98%)  2
Skin and subcutaneous tissue disorders     
Blister * 1  2/100 (2.00%)  2 0/101 (0.00%)  0
Hyperhidrosis * 1  2/100 (2.00%)  2 1/101 (0.99%)  1
Pruritus * 1  8/100 (8.00%)  8 3/101 (2.97%)  3
Pruritus generalised * 1  2/100 (2.00%)  2 0/101 (0.00%)  0
Vascular disorders     
Flushing * 1  3/100 (3.00%)  4 1/101 (0.99%)  3
1
Term from vocabulary, MedDRA (18.1)
*
Indicates events were collected by non-systematic assessment
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.
Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
Results Point of Contact
Name/Title: Randall Mack
Organization: Recro Pharma, Inc.
Phone: 484-395-2470 ext 2406
Responsible Party: Recro Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02675907     History of Changes
Other Study ID Numbers: REC-15-016
First Submitted: February 1, 2016
First Posted: February 5, 2016
Results First Submitted: July 24, 2017
Results First Posted: September 29, 2017
Last Update Posted: November 17, 2017