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Study of Meloxicam Capsules to Treat Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT01787188
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Meloxicam Test Capsules
Drug: Placebo Capsules
Enrollment 403
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description Meloxicam 5 mg: Capsules Meloxicam 10 mg: Capsules Placebo: Capsule
Period Title: Overall Study
Started 139 130 134
Completed 122 112 116
Not Completed 17 18 18
Reason Not Completed
Adverse Event             2             4             6
Lack of Efficacy             7             3             5
Non-compliance with Study Drug             0             1             0
Withdrawal by Subject             4             3             2
Protocol Violation             3             2             3
Lost to Follow-up             1             2             2
Other, including patient moved             0             3             0
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo Total
Hide Arm/Group Description Meloxicam 5 mg: Capsules Meloxicam 10 mg: Capsules Placebo: Capsule Total of all reporting groups
Overall Number of Baseline Participants 138 131 133 402
Hide Baseline Analysis Population Description
Subjects in this population received at least 1 dose of study drug and were analyzed according to treatment received, not treatment randomized. One subject who entered the study in the placebo group withdrew before receiving study drug. One subject who was randomized to meloxicam 5 mg received meloxicam 10 mg and was analyzed in that group
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 131 participants 133 participants 402 participants
60.8  (9.05) 60.2  (8.77) 61.1  (9.26) 60.7  (9.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 131 participants 133 participants 402 participants
Female
89
  64.5%
84
  64.1%
92
  69.2%
265
  65.9%
Male
49
  35.5%
47
  35.9%
41
  30.8%
137
  34.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 131 participants 133 participants 402 participants
Hispanic or Latino
10
   7.2%
12
   9.2%
11
   8.3%
33
   8.2%
Not Hispanic or Latino
128
  92.8%
119
  90.8%
122
  91.7%
369
  91.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 138 participants 131 participants 133 participants 402 participants
American Indian or Alaska Native 2 1 0 3
Asian 0 1 0 1
Black or African-American 27 29 23 79
Native Hawaiian or Other Pacific Islander 2 2 0 4
White 108 98 110 316
[1]
Measure Description: Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 138 participants 131 participants 133 participants 402 participants
89.0  (17.00) 85.9  (16.82) 89.2  (17.27) 88.1  (17.06)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 138 participants 131 participants 133 participants 402 participants
168.9  (10.28) 167.9  (9.66) 168.6  (10.37) 168.5  (10.10)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 138 participants 131 participants 133 participants 402 participants
31.1  (4.77) 30.5  (5.31) 31.3  (4.95) 30.9  (5.01)
Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 138 participants 131 participants 133 participants 402 participants
72.51  (15.360) 72.19  (13.938) 73.20  (15.472) 72.64  (14.922)
[1]
Measure Description:

The pain in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the mean of the visual analogue scale scores from 5 pain subscale questions, with 0 mm meaning "No Pain" and 100 mm meaning "Worst Possible Pain".

The pain subscore was calculated for 139 subjects in the Meloxicam 5 mg group, 130 in the Meloxicam 10 mg group, and 133 in the placebo group.

Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscore   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 138 participants 131 participants 133 participants 402 participants
66.83  (18.051) 67.66  (16.873) 68.61  (17.623) 67.69  (17.505)
[1]
Measure Description:

The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Worst Possible Functional Limitation".

The function subscale score was calculated for 138 subjects in the Meloxicam 5 mg group, 130 in the Meloxicam 10 mg group, and 132 in the placebo group.

Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscore   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 138 participants 131 participants 133 participants 402 participants
70.30  (18.367) 69.19  (19.569) 72.65  (17.056) 70.71  (18.363)
[1]
Measure Description:

The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions, with 0 mm meaning "No Stiffness" and 100 mm meaning "Worst Possible Stiffness".

The stiffness subscale score was calculated for 139 subjects in the Meloxicam 5 mg group, 130 in the Meloxicam 10 mg group, and 132 in the placebo group.

Baseline Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 138 participants 131 participants 133 participants 402 participants
68.27  (16.315) 68.74  (15.193) 69.75  (16.134) 68.91  (15.870)
[1]
Measure Description:

The pain, stiffness, and physical function in subjects with osteoarthritis were measured at baseline using the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The total WOMAC score is the average of the mean visual analogue scale scores, with 0 mm meaning "No Limitation" and 100 mm meaning "Extreme Limitation".

Baseline total WOMAC score was calculated for 138 subjects in the Meloxicam 5 mg once daily group, 130 subjects in the Meloxicam 10 mg once daily group, and 131 subjects in the placebo group.

1.Primary Outcome
Title Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Hide Description

The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".

The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 131 119 127
Least Squares Mean (Standard Error)
Unit of Measure: mm
-36.52  (2.485) -34.41  (2.678) -25.68  (2.636)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.84
Confidence Interval (2-Sided) 95%
-16.93 to -4.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.097
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0059
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -8.74
Confidence Interval (2-Sided) 95%
-14.94 to -2.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.154
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Hide Description

The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".

The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline.

Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 136 123 132
Least Squares Mean (Standard Error)
Unit of Measure: mm
-26.12  (2.217) -20.42  (2.397) -16.51  (2.367)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.61
Confidence Interval (2-Sided) 95%
-14.80 to -4.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.641
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1486
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -3.90
Confidence Interval (2-Sided) 95%
-9.20 to 1.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.696
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Hide Description

The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".

The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline.

Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 134 121 126
Least Squares Mean (Standard Error)
Unit of Measure: mm
-31.31  (2.339) -30.82  (2.531) -20.98  (2.503)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.33
Confidence Interval (2-Sided) 95%
-15.97 to -4.70
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.865
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.84
Confidence Interval (2-Sided) 95%
-15.58 to -4.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.917
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Hide Description

The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".

The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 139 128 133
Least Squares Mean (Standard Error)
Unit of Measure: mm
-30.51  (2.151) -27.89  (2.337) -20.07  (2.318)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.44
Confidence Interval (2-Sided) 95%
-15.40 to -5.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.521
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -7.82
Confidence Interval (2-Sided) 95%
-12.85 to -2.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.561
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
Hide Description

Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty".

The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline.

Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 132 123 130
Least Squares Mean (Standard Error)
Unit of Measure: mm
-21.62  (2.214) -15.67  (2.384) -11.28  (2.365)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.34
Confidence Interval (2-Sided) 95%
-15.49 to -5.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.623
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0997
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -4.39
Confidence Interval (2-Sided) 95%
-9.63 to 0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.662
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
Hide Description

Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty".

The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline.

Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 133 121 124
Least Squares Mean (Standard Error)
Unit of Measure: mm
-25.86  (2.367) -25.45  (2.554) -16.03  (2.537)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.83
Confidence Interval (2-Sided) 95%
-15.54 to -4.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.905
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.42
Confidence Interval (2-Sided) 95%
-15.22 to -3.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.951
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
Hide Description

Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty".

The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 130 119 125
Least Squares Mean (Standard Error)
Unit of Measure: mm
-29.85  (2.518) -29.71  (2.706) -19.72  (2.678)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.13
Confidence Interval (2-Sided) 95%
-16.32 to -3.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.147
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.98
Confidence Interval (2-Sided) 95%
-16.27 to -3.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.198
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
Hide Description

Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty".

The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 138 128 131
Least Squares Mean (Standard Error)
Unit of Measure: mm
-25.15  (2.205) -22.83  (2.389) -14.67  (2.379)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.47
Confidence Interval (2-Sided) 95%
-15.57 to -5.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.593
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -8.16
Confidence Interval (2-Sided) 95%
-13.33 to -2.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.627
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
Hide Description

The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation".

The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline.

Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 132 123 131
Least Squares Mean (Standard Error)
Unit of Measure: mm
-20.45  (2.270) -14.41  (2.445) -10.00  (2.423)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.45
Confidence Interval (2-Sided) 95%
-15.73 to -5.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.686
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1065
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -4.41
Confidence Interval (2-Sided) 95%
-9.77 to 0.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.725
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
Hide Description

The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation".

The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline.

Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 133 122 125
Least Squares Mean (Standard Error)
Unit of Measure: mm
-24.41  (2.419) -24.38  (2.608) -14.73  (2.590)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.68
Confidence Interval (2-Sided) 95%
-15.50 to -3.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.961
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.65
Confidence Interval (2-Sided) 95%
-15.56 to -3.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.006
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
Hide Description

The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation".

The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 130 121 126
Least Squares Mean (Standard Error)
Unit of Measure: mm
-28.21  (2.566) -28.40  (2.752) -17.95  (2.724)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.26
Confidence Interval (2-Sided) 95%
-16.54 to -3.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.194
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.45
Confidence Interval (2-Sided) 95%
-16.82 to -4.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.240
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
Hide Description

The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation".

The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 138 128 132
Least Squares Mean (Standard Error)
Unit of Measure: mm
-23.78  (2.254) -21.70  (2.441) -13.26  (2.429)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.52
Confidence Interval (2-Sided) 95%
-15.72 to -5.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.646
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -8.44
Confidence Interval (2-Sided) 95%
-13.71 to -3.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.680
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
Hide Description

The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness".

The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline.

Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 136 123 131
Least Squares Mean (Standard Error)
Unit of Measure: mm
-19.84  (2.381) -14.88  (2.578) -8.86  (2.545)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.98
Confidence Interval (2-Sided) 95%
-16.55 to -5.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.831
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0379
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -6.02
Confidence Interval (2-Sided) 95%
-11.71 to -0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.890
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
Hide Description

The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness".

The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline.

Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 134 121 125
Least Squares Mean (Standard Error)
Unit of Measure: mm
-26.52  (2.559) -23.39  (2.767) -14.30  (2.737)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -12.22
Confidence Interval (2-Sided) 95%
-18.42 to -6.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.152
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.10
Confidence Interval (2-Sided) 95%
-15.41 to -2.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.210
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
Hide Description

The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness".

The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 131 119 126
Least Squares Mean (Standard Error)
Unit of Measure: mm
-29.68  (2.691) -28.10  (2.902) -18.74  (2.857)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.94
Confidence Interval (2-Sided) 95%
-17.55 to -4.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.359
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0066
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.36
Confidence Interval (2-Sided) 95%
-16.09 to -2.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.422
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
Hide Description

The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness".

The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description:
Meloxicam 5 mg: Capsules
Meloxicam 10 mg: Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 138 128 132
Least Squares Mean (Standard Error)
Unit of Measure: mm
-24.76  (2.345) -21.33  (2.548) -13.09  (2.526)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam 5 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -11.67
Confidence Interval (2-Sided) 95%
-17.08 to -6.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.751
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Meloxicam 10 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -8.24
Confidence Interval (2-Sided) 95%
-13.74 to -2.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.795
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects in this population received at least 1 dose of study drug and were analyzed according to treatment received, not treatment randomized. One subject who entered the study in the placebo group withdrew before receiving study drug. One subject who was randomized to meloxicam 5 mg received meloxicam 10 mg and was analyzed in that group
 
Arm/Group Title Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Hide Arm/Group Description Meloxicam 5 mg: Capsules Meloxicam 10 mg: Capsules Placebo: Capsule
All-Cause Mortality
Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)   0/131 (0.00%)   0/133 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Meloxicam 5 mg Once Daily Meloxicam 10 mg Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/138 (10.14%)   13/131 (9.92%)   10/133 (7.52%) 
Gastrointestinal disorders       
Diarrhea  4/138 (2.90%)  3/131 (2.29%)  1/133 (0.75%) 
Nausea  3/138 (2.17%)  3/131 (2.29%)  0/133 (0.00%) 
Abdominal Discomfort  1/138 (0.72%)  3/131 (2.29%)  0/133 (0.00%) 
Infections and infestations       
Urinary Tract Infection  3/138 (2.17%)  2/131 (1.53%)  3/133 (2.26%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis  4/138 (2.90%)  1/131 (0.76%)  3/133 (2.26%) 
Nervous system disorders       
Headache  2/138 (1.45%)  5/131 (3.82%)  4/133 (3.01%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Solorio, Executive Director of Clinical Operations
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-3150
EMail: dsolorio@iroko.com
Layout table for additonal information
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01787188     History of Changes
Other Study ID Numbers: MEL3-12-02
First Submitted: February 6, 2013
First Posted: February 8, 2013
Results First Submitted: February 6, 2015
Results First Posted: March 11, 2015
Last Update Posted: March 11, 2015