Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01430559
• Collaborator: (none)
• Enrollment: 408
• Locations: 25
• Arms: 2
• Actual Duration (Months): 17.1
• Patients Per Site: 16.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Drug: Meloxicam; Drug: Placebo	N/A

Detailed Description

To validate culturally the WOMAC tool in mainland China and observe the different response of meloxicam and placebo in a patient population with osteoarthritis of the knee

Study Design

• Study Type: Interventional
• Actual Enrollment: 408 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
• Actual Study Start Date: Oct 24, 2011
• Actual Primary Completion Date: Mar 27, 2013
• Actual Study Completion Date: Mar 27, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Meloxicam	Drug: Meloxicam; 7.5mg x2 once a day for 12 weeks; Other Names: Mobic
Placebo Comparator: Placebo 2 Placebo capsules once a day for 12 weeks	Drug: Placebo; Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.

Outcome Measures

Primary Outcome Measures

1. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary) [Screening 1 (Visit 1: Days -21 to -14)]

   The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.

2. WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary [Screening 2 (Visit 2: Days -14 to -10)]

   The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.

3. WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary [Baseline (Day 1)]

   The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.

4. WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary [Visit 8 (Week 12)]

   The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.

5. Change From Baseline in WOMAC Pain Subscale Scores at Week 12 [Baseline and Week 12]

   WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.

Secondary Outcome Measures

1. Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8 and 12]

   The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. Change from baseline was calculated for each WOMAC subscale (pain, stiffness, physical function) and WOMAC average score.

2. Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8 and 12]

   WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. Change from baseline in two of the WOMAC pain subscale items: pain when walking on a flat surface, and pain when going up or down stairs were calculated.

3. Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 [Baseline and Week 12]

   WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions. WOMAC pain subscale response rates at Week 12 were shown for the reductions from Baseline of greater than (>) 0%, 10% to 90% (in steps of 10%).

4. Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 [Baseline, Weeks 2, 4, 8 and 12]

   WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.

5. Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8 and 12]

   PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 scores with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis.

6. Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 [Baseline, Weeks 2, 4, 8 and 12]

   PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 grades with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis. The treatment response of an improvement of >=2 points from Baseline in PGAO were summarized.

7. Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 [Baseline and Week 12]

   The SF-36 is a self-administered questionnaire that measures each of the following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.

8. Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 [Baseline and Week 12]

   The EQ-5D is a generic measure of health related quality of life. The EQ-5D has 5 items that assess the level of difficulty (none [score of 1], some/moderate [score of 2], extreme [score of 3]) respondents report for 5 health status domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The change from Baseline (decrease by 2, 1, 0, -1 and -2) at Week 12 in each of the 5 health status domains were summarized.

9. Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8 and 12]

   Daily average knee pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. The participants described their pain in the index knee during the past 24 hours by choosing the appropriate number from 0 to 10.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Subjects are required to meet the following criteria to be eligible for Randomization into this study:

• Male or female Chinese subjects, 18-75 years of age;

• Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. & Lawrence J, 1957)

• Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

• History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee.

• Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.

• Signs and symptoms of clinically significant cardiac disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Province Hospital	Hefei	Anhui	China	230001
2	The Third Affiliated Hospital Of Sun Yat-sen University	Guangzhou	Guangdong	China	510630
3	The First Affiliated Hospital of Shantou Medical Collage	Shantou City	Guangdong	China	515041
4	Rheumatology Department, The first Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
5	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
6	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029
7	Rheumatology Department, The First Hospital of China Medical University	Shenyang	Liaoning	China
8	QiLu Hospital of Shandong University	Jinan	Shandong	China	250012
9	Liaocheng People's Hospital/Orthopaedics	Liaocheng	Shandong	China	252000
10	Department of Immunology and Rheumatology, Qingdao Municipal Hospital	Qingdao	Shandong	China	266011
11	Department of Immunology and Rheumatology,Qingdao Municipal Hospital	Qingdao	Shandong	China	266011
12	Xijing Hospital, The Fourth Military Medical University	Xi'an	Shanxi	China	710032
13	Department of Orthopedics, West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041
14	Department of Rheumatology and Immunology,West China Hospital of Sichuan University	Chengdu	Sichuan	China	610044
15	Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital	Chengdu	Sichuan	China	610072
16	Sichuan Provincial People's Hospital, Rheumatology	Chengdu	Sichuan	China	610072
17	China-Japan Friendship Hospital/Rheumatology Department	Beijing		China	100029
18	Peking Union Medical College Hospital	Beijing		China	100032
19	Li Zhanguo	Beijing		China	100044
20	Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University	Beijing		China	100053
21	Peking Union Medical College Hospital, Orthopaedics	Beijing		China	100730
22	Renji Hospital Shanghai Jiao Tong University School of Medicine	Shanghai		China	200001
23	Rheumatology and Immunology Department, Shanghai Changzheng Hospital	Shanghai		China	200003
24	Zhongshan Hospital Fudan University, Rheumatology Department	Shanghai		China	200032
25	Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital	Tianjin		China	300052

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01430559
• Other Study ID Numbers: A9001449
• First Posted: Sep 8, 2011
• Last Update Posted: Dec 31, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Meloxicam

Study Results

Participant Flow

Recruitment Details	A total of 24 centers in mainland China recruited study participants, starting from 24 Oct 2011 to 14 Dec 2012.
Pre-assignment Detail	This study comprised of a Screening Period prior to Treatment Period. During Screening, 52 healthy participants and 356 participants with osteoarthritis (OA) were included in validation analysis set (total enrollment=408), 293 out of the 356 OA participants were assigned randomized to treatment, and 6 of these randomized participants did not receive actual treatment.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Period Title: Overall Study
STARTED	146	147
Treated	143	144
COMPLETED	126	135
NOT COMPLETED	20	12

Baseline Characteristics

Arm/Group Title	Placebo	Meloxicam 15 mg	Total
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.	Total of all reporting groups
Overall Participants	143	144	287
Age, Customized (Count of Participants)
26 to 35 years	1 0.7%	1 0.7%	2 0.7%
36 to 45 years	4 2.8%	12 8.3%	16 5.6%
46 to 55 years	43 30.1%	44 30.6%	87 30.3%
56 to 65 years	61 42.7%	60 41.7%	121 42.2%
66 to 75 years	34 23.8%	27 18.8%	61 21.3%
Sex: Female, Male (Count of Participants)
Female	106 74.1%	122 84.7%	228 79.4%
Male	37 25.9%	22 15.3%	59 20.6%

Outcome Measures

1. Primary Outcome

Title	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary)
Description	The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame	Screening 1 (Visit 1: Days -21 to -14)

Outcome Measure Data

Analysis Population Description

Validation Analysis Set (VAS) - all OA participants who were non-screen failure at Visit 1 (Screening 1) and returned for Visit 2 (Screening 2); and all enrolled healthy participants. Here, n=number of evaluable participants for each specific category.

Arm/Group Title	OA Participants	Healthy Participants
Arm/Group Description	Participants with OA who responded to the WOMAC questionnaire.	Healthy participants who responded to the WOMAC questionnaire.
Measure Participants	356	52
Pain subscale (paper worksheet)	5.7 (1.47)
Stiffness subscale (paper worksheet)	5.3 (1.94)
Physical function subscale (paper worksheet)	5.7 (1.56)
Total (paper worksheet)	135.9 (35.59)
Pain subscale (e-dary)	5.7 (1.47)	0.1 (0.22)
Stiffness subscale (e-diary)	5.3 (2.00)	0.1 (0.31)
Physical function subscale (e-diary)	5.7 (1.56)	0.0 (0.14)
Total (e-diary)	136.0 (35.92)	0.8 (3.66)

2. Primary Outcome

Title	WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary
Description	The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame	Screening 2 (Visit 2: Days -14 to -10)

Outcome Measure Data

Analysis Population Description

VAS: all OA participants who were non-screen failure at Visit 1 (Screening 1) and returned for Visit 2 (Screening 2).

Arm/Group Title	OA Participants
Arm/Group Description	Participants with OA who responded to the WOMAC questionnaire.
Measure Participants	356
Pain subscale score	5.6 (1.46)
Stiffness subscale score	5.4 (1.76)
Physical function subscale score	5.8 (1.52)
Total score	136.6 (35.38)

3. Primary Outcome

Title	WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
Description	The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame	Baseline (Day 1)

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	139	139
Pain subscale score	6.0 (1.29)	6.0 (1.32)
Stiffness subscale score	5.7 (1.56)	5.6 (1.65)
Physical function subscale score	6.1 (1.32)	6.1 (1.22)
Total score	145.0 (31.05)	144.8 (29.57)

4. Primary Outcome

Title	WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary
Description	The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame	Visit 8 (Week 12)

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	101	119
Pain subscale score	4.4 (2.05)	3.6 (1.90)
Stiffness subscale score	4.2 (2.26)	3.5 (1.96)
Physical function subscale score	4.5 (2.08)	3.7 (1.87)
Total score	106.6 (49.70)	88.7 (44.45)

5. Primary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Scores at Week 12
Description	WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using Baseline Observation Carried Forward (BOCF) imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	139	139
Least Squares Mean (95% Confidence Interval) [units on a scale]	-1.24	-2.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from analysis of covariance (ANCOVA, repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.82
	Confidence Interval	(2-Sided) 95%; -1.20 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12
Description	The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. Change from baseline was calculated for each WOMAC subscale (pain, stiffness, physical function) and WOMAC average score.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	139	139
Pain subscale (Week 2)	-0.76	-1.12
Pain subscale (Week 4)	-1.18	-1.53
Pain subscale (Week 8)	-1.31	-1.82
Pain subscale (Week 12)	-1.24	-2.06
Stiffness subscale (Week 2)	-0.78	-1.11
Stiffness subscale (Week 4)	-1.14	-1.34
Stiffness subscale (Week 8)	-1.23	-1.70
Stiffness subscale (Week 12)	-1.20	-1.86
Physical function subscale (Week 2)	-0.77	-1.21
Physical function subscale (Week 4)	-1.18	-1.53
Physical function subscale (Week 8)	-1.31	-1.82
Physical function subscale (Week 12)	-1.25	-2.06
Average score (Week 2)	-0.77	-1.15
Average score (Week 4)	-1.17	-1.47
Average score (Week 8)	-1.29	-1.78
Average score (Week 12)	-1.23	-2.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Pain subscale (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0103
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95%; -0.65 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Pain subscale (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0295
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95%; -0.67 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.16
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Pain subscale (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0041
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -0.87 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Pain subscale (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.82
	Confidence Interval	(2-Sided) 95%; -1.20 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Stiffness subscale (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0369
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -0.64 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.16
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Stiffness subscale (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2642
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.54 to 0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Stiffness subscale (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0140
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -0.84 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Stiffness subscale (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.67
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.20
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Physical function subscale (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0017
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 95%; -0.72 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Physical function subscale (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0328
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95%; -0.66 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.16
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Physical function subscale (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0043
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.86 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Physical function subscale (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.81
	Confidence Interval	(2-Sided) 95%; -1.19 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Average score (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0051
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95%; -0.65 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Average score (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0593
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 95%; -0.61 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.16
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Average score (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0046
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 95%; -0.84 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Average score (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95%; -1.14 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12
Description	WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. Change from baseline in two of the WOMAC pain subscale items: pain when walking on a flat surface, and pain when going up or down stairs were calculated.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	139	139
Walking on flat surface (Week 2)	-0.51	-1.13
Walking on flat surface (Week 4)	-1.04	-1.61
Walking on flat surface (Week 8)	-1.17	-1.87
Walking on flat surface (Week 12)	-1.05	-1.97
Going up or down stairs (Week 2)	-1.00	-1.35
Going up or down stairs (Week 4)	-1.34	-1.74
Going up or down stairs (Week 8)	-1.53	-2.09
Going up or down stairs (Week 12)	-1.34	-2.43

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Walking on flat surface (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.16
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Walking on flat surface (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0015
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -0.92 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Walking on flat surface (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.08 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Walking on flat surface (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95%; -1.34 to -0.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.21
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Going up or down stairs (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0363
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95%; -0.67 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Going up or down stairs (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0311
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -0.75 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Going up or down stairs (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0057
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.20
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Going up or down stairs (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.08
	Confidence Interval	(2-Sided) 95%; -1.52 to -0.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12
Description	WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions. WOMAC pain subscale response rates at Week 12 were shown for the reductions from Baseline of greater than (>) 0%, 10% to 90% (in steps of 10%).
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	139	139
>0% reduction	53.1 37.1%	75.7 52.6%
Greater than or equal to (>=) 10% reduction	46.2 32.3%	67.4 46.8%
>=20% reduction	37.1 25.9%	58.3 40.5%
>=30% reduction	29.4 20.6%	49.3 34.2%
>=40% reduction	22.4 15.7%	43.8 30.4%
>=50% reduction	16.1 11.3%	34.0 23.6%
>=60% reduction	10.5 7.3%	24.3 16.9%
>=70% reduction	7.7 5.4%	12.5 8.7%
>=80% reduction	4.2 2.9%	6.3 4.4%
>=90% reduction	2.1 1.5%	3.5 2.4%

9. Secondary Outcome

Title	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12
Description	WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 9 participants (4 placebo, 5 meloxicam) who had missing baseline WOMAC data.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	143	144
>=30% reduction (Week 2)	17.48 12.2%	22.92 15.9%
>=30% reduction (Week 4)	30.07 21%	36.81 25.6%
>=30% reduction (Week 8)	34.97 24.5%	45.14 31.3%
>=30% reduction (Week 12)	29.37 20.5%	49.31 34.2%
>=50% reduction (Week 2)	4.90 3.4%	9.03 6.3%
>=50% reduction (Week 4)	9.09 6.4%	14.58 10.1%
>=50% reduction (Week 8)	13.29 9.3%	24.31 16.9%
>=50% reduction (Week 12)	16.08 11.2%	34.03 23.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=30% reduction (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2373
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.42
	Confidence Interval	(2-Sided) 95%; 0.79 to 2.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=30% reduction (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2069
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95%; 0.84 to 2.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=30% reduction (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0680
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95%; 0.97 to 2.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=30% reduction (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.41
	Confidence Interval	(2-Sided) 95%; 1.47 to 3.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=50% reduction (Week 2)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1736
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.94
	Confidence Interval	(2-Sided) 95%; 0.75 to 5.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=50% reduction (Week 4)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1496
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.72
	Confidence Interval	(2-Sided) 95%; 0.82 to 3.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=50% reduction (Week 8)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0171
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.12
	Confidence Interval	(2-Sided) 95%; 1.14 to 3.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	>=50% reduction (Week 12)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.77
	Confidence Interval	(2-Sided) 95%; 1.57 to 4.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12
Description	PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 scores with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	140	139
Week 2	-0.27	-0.45
Week 4	-0.37	-0.53
Week 8	-0.34	-0.52
Week 12	-0.43	-0.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0027
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.31 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 4
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0308
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -0.30 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
Statistical Test of Hypothesis	p-Value	0.0060
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.31 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0076
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.34 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments

11. Secondary Outcome

Title	Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12
Description	PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 grades with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis. The treatment response of an improvement of >=2 points from Baseline in PGAO were summarized.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 8 participants (3 placebo, 5 meloxicam) who had missing baseline PGAO data.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	143	144
Week 2	2.80 2%	4.86 3.4%
Week 4	6.29 4.4%	11.81 8.2%
Week 8	5.59 3.9%	6.25 4.3%
Week 12	8.39 5.9%	13.19 9.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2843
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.13
	Confidence Interval	(2-Sided) 95%; 0.53 to 8.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 4
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1050
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.05
	Confidence Interval	(2-Sided) 95%; 0.86 to 4.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.7861
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95%; 0.40 to 3.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1873
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.71
	Confidence Interval	(2-Sided) 95%; 0.77 to 3.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12
Description	The SF-36 is a self-administered questionnaire that measures each of the following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, n=number of evaluable participants for each specific SF-36 domain.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	143	144
General health	4.60	5.98
Physical functioning	6.95	12.88
Role physical	5.79	13.95
Bodily pain	7.51	14.87
Vitality	5.03	7.08
Social functioning	6.06	12.02
Role emotional	4.65	10.52
Mental health	4.50	5.07
Mental component aggregate	2.19	3.14
Physical component aggregate	2.65	5.21

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	General health
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3738
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95%; -1.67 to 4.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.55
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Physical functioning
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0028
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	5.94
	Confidence Interval	(2-Sided) 95%; 2.07 to 9.80
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.96
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Role physical
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	8.16
	Confidence Interval	(2-Sided) 95%; 3.95 to 12.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.14
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Bodily pain
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	7.36
	Confidence Interval	(2-Sided) 95%; 4.10 to 10.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.66
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Vitality
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2124
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.05
	Confidence Interval	(2-Sided) 95%; -1.18 to 5.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.64
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Social functioning
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0050
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	5.96
	Confidence Interval	(2-Sided) 95%; 1.82 to 10.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.10
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Role emotional
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0093
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	5.87
	Confidence Interval	(2-Sided) 95%; 1.46 to 10.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.24
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Mental health
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.7274
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95%; -2.66 to 3.81
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.64
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Mental component aggregate
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2819
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; -0.78 to 2.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.88
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Physical component aggregate
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.57
	Confidence Interval	(2-Sided) 95%; 1.27 to 3.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.66
	Estimation Comments

13. Secondary Outcome

Title	Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12
Description	The EQ-5D is a generic measure of health related quality of life. The EQ-5D has 5 items that assess the level of difficulty (none [score of 1], some/moderate [score of 2], extreme [score of 3]) respondents report for 5 health status domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The change from Baseline (decrease by 2, 1, 0, -1 and -2) at Week 12 in each of the 5 health status domains were summarized.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 12 participants (5 placebo, 7 meloxicam) who had missing baseline EQ-5D data.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	143	144
Mobility (decrease by 2)	0 0%	0 0%
Mobility (decrease by 1)	2.8 2%	0.7 0.5%
Mobility (decrease by 0)	79.7 55.7%	66.0 45.8%
Mobility (decrease by -1)	14.0 9.8%	28.5 19.8%
Mobility (decrease by -2)	0 0%	0 0%
Self-care (decrease by 2)	0 0%	0 0%
Self-care (decrease by 1)	3.5 2.4%	4.2 2.9%
Self-care (decrease by 0)	67.8 47.4%	55.6 38.6%
Self-care (decrease by -1)	25.2 17.6%	35.4 24.6%
Self-care (decrease by -2)	0 0%	0 0%
Usual activities (decrease by 2)	0 0%	0 0%
Usual activities (decrease by 1)	0.7 0.5%	2.8 1.9%
Usual activities (decrease by 0)	81.1 56.7%	63.2 43.9%
Usual activities (decrease by -1)	14.7 10.3%	29.2 20.3%
Usual activities (decrease by -2)	0 0%	0 0%
Pain/discomfort (decrease by 2)	0 0%	0 0%
Pain/discomfort (decrease by 1)	2.1 1.5%	2.1 1.5%
Pain/discomfort (decrease by 0)	77.6 54.3%	67.4 46.8%
Pain/discomfort (decrease by -1)	15.4 10.8%	25.0 17.4%
Pain/discomfort (decrease by -2)	1.4 1%	0.7 0.5%
Anxiety/depression (decrease by 2)	0.7 0.5%	0 0%
Anxiety/depression (decrease by 1)	7.7 5.4%	6.3 4.4%
Anxiety/depression (decrease by 0)	72.0 50.3%	67.4 46.8%
Anxiety/depression (decrease by -1)	14.7 10.3%	20.8 14.4%
Anxiety/depression (decrease by -2)	1.4 1%	0.7 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Mobility
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0014
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.60
	Confidence Interval	(2-Sided) 95%; 1.45 to 4.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Self-care
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1080
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.51
	Confidence Interval	(2-Sided) 95%; 0.91 to 2.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Usual activities
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0119
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.06
	Confidence Interval	(2-Sided) 95%; 1.17 to 3.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Pain/discomfort
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0887
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.62
	Confidence Interval	(2-Sided) 95%; 0.93 to 2.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Anxiety/depression
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2466
	Comments	P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.37
	Confidence Interval	(2-Sided) 95%; 0.80 to 2.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12
Description	Daily average knee pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. The participants described their pain in the index knee during the past 24 hours by choosing the appropriate number from 0 to 10.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.

Arm/Group Title	Placebo	Meloxicam 15 mg
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Measure Participants	141	143
Week 2	-0.67	-0.97
Week 4	-1.11	-1.42
Week 8	-1.31	-1.76
Week 12	-1.43	-2.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0367
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 95%; -0.58 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 4
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0652
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.65 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0200
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	OA Participants, Healthy Participants
	Comments	Week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0016
	Comments	P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95%; -1.02 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.20
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Placebo		Meloxicam 15 mg		OA Participants Not Randomized		OA Participants Randomized But Not Treated		Healthy Participants
Arm/Group Description	Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.		Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.		OA participants in VAS who were not randomized to placebo or meloxicam treatment.		OA participants who were randomized but did not receive actual placebo or meloxicam treatment.		Healthy participants who were included in validation part of the study.
All Cause Mortality
	Placebo		Meloxicam 15 mg		OA Participants Not Randomized		OA Participants Randomized But Not Treated		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Meloxicam 15 mg		OA Participants Not Randomized		OA Participants Randomized But Not Treated		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/143 (1.4%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Cardiac disorders
Angina unstable	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
General disorders
Asthenia	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Investigations
Haemoglobin decreased	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Platelet count decreased	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Red blood cell count decreased	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Weight decreased	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
White blood cell count decreased	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Skin and subcutaneous tissue disorders
Rash	1/143 (0.7%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Meloxicam 15 mg		OA Participants Not Randomized		OA Participants Randomized But Not Treated		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/143 (0%)		0/144 (0%)		0/63 (0%)		0/6 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.