Trial Outcomes & Findings for Study of Meloxicam Capsules to Treat Osteoarthritis Pain (NCT NCT01787188)

NCT ID: NCT01787188

Last Updated: 2015-03-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

403 participants

Primary outcome timeframe

Baseline to Week 12/Early Termination

Results posted on

2015-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Meloxicam 5 mg Once Daily Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily Meloxicam 10 mg: Capsules	Placebo Placebo: Capsule
Overall Study STARTED	139	130	134
Overall Study COMPLETED	122	112	116
Overall Study NOT COMPLETED	17	18	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Meloxicam 5 mg Once Daily Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily Meloxicam 10 mg: Capsules	Placebo Placebo: Capsule
Overall Study Adverse Event	2	4	6
Overall Study Lack of Efficacy	7	3	5
Overall Study Non-compliance with Study Drug	0	1	0
Overall Study Withdrawal by Subject	4	3	2
Overall Study Protocol Violation	3	2	3
Overall Study Lost to Follow-up	1	2	2
Overall Study Other, including patient moved	0	3	0

Baseline Characteristics

Study of Meloxicam Capsules to Treat Osteoarthritis Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meloxicam 5 mg Once Daily n=138 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=131 Participants Meloxicam 10 mg: Capsules	Placebo n=133 Participants Placebo: Capsule	Total n=402 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 9.05 • n=39 Participants	60.2 years STANDARD_DEVIATION 8.77 • n=41 Participants	61.1 years STANDARD_DEVIATION 9.26 • n=35 Participants	60.7 years STANDARD_DEVIATION 9.01 • n=31 Participants
Sex: Female, Male Female	89 Participants n=39 Participants	84 Participants n=41 Participants	92 Participants n=35 Participants	265 Participants n=31 Participants
Sex: Female, Male Male	49 Participants n=39 Participants	47 Participants n=41 Participants	41 Participants n=35 Participants	137 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=39 Participants	12 Participants n=41 Participants	11 Participants n=35 Participants	33 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=39 Participants	119 Participants n=41 Participants	122 Participants n=35 Participants	369 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=39 Participants	1 participants n=41 Participants	0 participants n=35 Participants	3 participants n=31 Participants
Race/Ethnicity, Customized Asian	0 participants n=39 Participants	1 participants n=41 Participants	0 participants n=35 Participants	1 participants n=31 Participants
Race/Ethnicity, Customized Black or African-American	27 participants n=39 Participants	29 participants n=41 Participants	23 participants n=35 Participants	79 participants n=31 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 participants n=39 Participants	2 participants n=41 Participants	0 participants n=35 Participants	4 participants n=31 Participants
Race/Ethnicity, Customized White	108 participants n=39 Participants	98 participants n=41 Participants	110 participants n=35 Participants	316 participants n=31 Participants
Weight	89.0 kg STANDARD_DEVIATION 17.00 • n=39 Participants	85.9 kg STANDARD_DEVIATION 16.82 • n=41 Participants	89.2 kg STANDARD_DEVIATION 17.27 • n=35 Participants	88.1 kg STANDARD_DEVIATION 17.06 • n=31 Participants
Height	168.9 cm STANDARD_DEVIATION 10.28 • n=39 Participants	167.9 cm STANDARD_DEVIATION 9.66 • n=41 Participants	168.6 cm STANDARD_DEVIATION 10.37 • n=35 Participants	168.5 cm STANDARD_DEVIATION 10.10 • n=31 Participants
Body Mass Index	31.1 kg/m^2 STANDARD_DEVIATION 4.77 • n=39 Participants	30.5 kg/m^2 STANDARD_DEVIATION 5.31 • n=41 Participants	31.3 kg/m^2 STANDARD_DEVIATION 4.95 • n=35 Participants	30.9 kg/m^2 STANDARD_DEVIATION 5.01 • n=31 Participants
Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score	72.51 mm STANDARD_DEVIATION 15.360 • n=39 Participants	72.19 mm STANDARD_DEVIATION 13.938 • n=41 Participants	73.20 mm STANDARD_DEVIATION 15.472 • n=35 Participants	72.64 mm STANDARD_DEVIATION 14.922 • n=31 Participants
Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscore	66.83 mm STANDARD_DEVIATION 18.051 • n=39 Participants	67.66 mm STANDARD_DEVIATION 16.873 • n=41 Participants	68.61 mm STANDARD_DEVIATION 17.623 • n=35 Participants	67.69 mm STANDARD_DEVIATION 17.505 • n=31 Participants
Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscore	70.30 mm STANDARD_DEVIATION 18.367 • n=39 Participants	69.19 mm STANDARD_DEVIATION 19.569 • n=41 Participants	72.65 mm STANDARD_DEVIATION 17.056 • n=35 Participants	70.71 mm STANDARD_DEVIATION 18.363 • n=31 Participants
Baseline Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score	68.27 mm STANDARD_DEVIATION 16.315 • n=39 Participants	68.74 mm STANDARD_DEVIATION 15.193 • n=41 Participants	69.75 mm STANDARD_DEVIATION 16.134 • n=35 Participants	68.91 mm STANDARD_DEVIATION 15.870 • n=31 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=131 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=119 Participants Meloxicam 10 mg: Capsules	Placebo n=127 Participants Placebo: Capsule
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.	-36.52 mm Standard Error 2.485	-34.41 mm Standard Error 2.678	-25.68 mm Standard Error 2.636

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=136 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=123 Participants Meloxicam 10 mg: Capsules	Placebo n=132 Participants Placebo: Capsule
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.	-26.12 mm Standard Error 2.217	-20.42 mm Standard Error 2.397	-16.51 mm Standard Error 2.367

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=134 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=121 Participants Meloxicam 10 mg: Capsules	Placebo n=126 Participants Placebo: Capsule
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.	-31.31 mm Standard Error 2.339	-30.82 mm Standard Error 2.531	-20.98 mm Standard Error 2.503

SECONDARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=139 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=128 Participants Meloxicam 10 mg: Capsules	Placebo n=133 Participants Placebo: Capsule
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.	-30.51 mm Standard Error 2.151	-27.89 mm Standard Error 2.337	-20.07 mm Standard Error 2.318

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=132 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=123 Participants Meloxicam 10 mg: Capsules	Placebo n=130 Participants Placebo: Capsule
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.	-21.62 mm Standard Error 2.214	-15.67 mm Standard Error 2.384	-11.28 mm Standard Error 2.365

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=133 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=121 Participants Meloxicam 10 mg: Capsules	Placebo n=124 Participants Placebo: Capsule
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.	-25.86 mm Standard Error 2.367	-25.45 mm Standard Error 2.554	-16.03 mm Standard Error 2.537

SECONDARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=130 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=119 Participants Meloxicam 10 mg: Capsules	Placebo n=125 Participants Placebo: Capsule
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.	-29.85 mm Standard Error 2.518	-29.71 mm Standard Error 2.706	-19.72 mm Standard Error 2.678

SECONDARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=138 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=128 Participants Meloxicam 10 mg: Capsules	Placebo n=131 Participants Placebo: Capsule
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.	-25.15 mm Standard Error 2.205	-22.83 mm Standard Error 2.389	-14.67 mm Standard Error 2.379

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=132 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=123 Participants Meloxicam 10 mg: Capsules	Placebo n=131 Participants Placebo: Capsule
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.	-20.45 mm Standard Error 2.270	-14.41 mm Standard Error 2.445	-10.00 mm Standard Error 2.423

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=133 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=122 Participants Meloxicam 10 mg: Capsules	Placebo n=125 Participants Placebo: Capsule
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.	-24.41 mm Standard Error 2.419	-24.38 mm Standard Error 2.608	-14.73 mm Standard Error 2.590

SECONDARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=130 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=121 Participants Meloxicam 10 mg: Capsules	Placebo n=126 Participants Placebo: Capsule
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.	-28.21 mm Standard Error 2.566	-28.40 mm Standard Error 2.752	-17.95 mm Standard Error 2.724

SECONDARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=138 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=128 Participants Meloxicam 10 mg: Capsules	Placebo n=132 Participants Placebo: Capsule
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.	-23.78 mm Standard Error 2.254	-21.70 mm Standard Error 2.441	-13.26 mm Standard Error 2.429

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=136 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=123 Participants Meloxicam 10 mg: Capsules	Placebo n=131 Participants Placebo: Capsule
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.	-19.84 mm Standard Error 2.381	-14.88 mm Standard Error 2.578	-8.86 mm Standard Error 2.545

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=134 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=121 Participants Meloxicam 10 mg: Capsules	Placebo n=125 Participants Placebo: Capsule
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.	-26.52 mm Standard Error 2.559	-23.39 mm Standard Error 2.767	-14.30 mm Standard Error 2.737

SECONDARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=131 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=119 Participants Meloxicam 10 mg: Capsules	Placebo n=126 Participants Placebo: Capsule
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.	-29.68 mm Standard Error 2.691	-28.10 mm Standard Error 2.902	-18.74 mm Standard Error 2.857

SECONDARY outcome

Timeframe: Baseline to Week 12/Early Termination

Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 5 mg Once Daily n=138 Participants Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=128 Participants Meloxicam 10 mg: Capsules	Placebo n=132 Participants Placebo: Capsule
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.	-24.76 mm Standard Error 2.345	-21.33 mm Standard Error 2.548	-13.09 mm Standard Error 2.526

Adverse Events

Meloxicam 5 mg Once Daily

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Meloxicam 10 mg Once Daily

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

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

Other adverse events
Measure	Meloxicam 5 mg Once Daily n=138 participants at risk Meloxicam 5 mg: Capsules	Meloxicam 10 mg Once Daily n=131 participants at risk Meloxicam 10 mg: Capsules	Placebo n=133 participants at risk Placebo: Capsule
Gastrointestinal disorders Diarrhea	2.9% 4/138 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	2.3% 3/131 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	0.75% 1/133 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
Nervous system disorders Headache	1.4% 2/138 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	3.8% 5/131 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	3.0% 4/133 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
Gastrointestinal disorders Nausea	2.2% 3/138 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	2.3% 3/131 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	0.00% 0/133 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
Musculoskeletal and connective tissue disorders Osteoarthritis	2.9% 4/138 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	0.76% 1/131 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	2.3% 3/133 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
Infections and infestations Urinary Tract Infection	2.2% 3/138 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	1.5% 2/131 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	2.3% 3/133 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
Gastrointestinal disorders Abdominal Discomfort	0.72% 1/138 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	2.3% 3/131 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	0.00% 0/133 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

Additional Information

Daniel Solorio, Executive Director of Clinical Operations

Iroko Pharmaceuticals, LLC

Phone: 267-546-3150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place