Adults 18 to 75, any sex, with Osteoarthritis of the Knee. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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. T
Pain subscale (paper worksheet)
Group
Value
95% CI
OA Participants
5.7
± 1.47
Stiffness subscale (paper worksheet)
Group
Value
95% CI
OA Participants
5.3
± 1.94
Physical function subscale (paper worksheet)
Group
Value
95% CI
OA Participants
5.7
± 1.56
Total (paper worksheet)
Group
Value
95% CI
OA Participants
135.9
± 35.59
Pain subscale (e-dary)
Group
Value
95% CI
OA Participants
5.7
± 1.47
Healthy Participants
0.1
± 0.22
Stiffness subscale (e-diary)
Group
Value
95% CI
OA Participants
5.3
± 2.00
Healthy Participants
0.1
± 0.31
Physical function subscale (e-diary)
Group
Value
95% CI
OA Participants
5.7
± 1.56
Healthy Participants
0.0
± 0.14
Total (e-diary)
Group
Value
95% CI
OA Participants
136.0
± 35.92
Healthy Participants
0.8
± 3.66
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diaryPrimary· 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. T
Pain subscale score
Group
Value
95% CI
OA Participants
5.6
± 1.46
Stiffness subscale score
Group
Value
95% CI
OA Participants
5.4
± 1.76
Physical function subscale score
Group
Value
95% CI
OA Participants
5.8
± 1.52
Total score
Group
Value
95% CI
OA Participants
136.6
± 35.38
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diaryPrimary· 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. T
Pain subscale score
Group
Value
95% CI
Placebo
6.0
± 1.29
Meloxicam 15 mg
6.0
± 1.32
Stiffness subscale score
Group
Value
95% CI
Placebo
5.7
± 1.56
Meloxicam 15 mg
5.6
± 1.65
Physical function subscale score
Group
Value
95% CI
Placebo
6.1
± 1.32
Meloxicam 15 mg
6.1
± 1.22
Total score
Group
Value
95% CI
Placebo
145.0
± 31.05
Meloxicam 15 mg
144.8
± 29.57
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diaryPrimary· 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. T
Pain subscale score
Group
Value
95% CI
Placebo
4.4
± 2.05
Meloxicam 15 mg
3.6
± 1.90
Stiffness subscale score
Group
Value
95% CI
Placebo
4.2
± 2.26
Meloxicam 15 mg
3.5
± 1.96
Physical function subscale score
Group
Value
95% CI
Placebo
4.5
± 2.08
Meloxicam 15 mg
3.7
± 1.87
Total score
Group
Value
95% CI
Placebo
106.6
± 49.70
Meloxicam 15 mg
88.7
± 44.45
Change From Baseline in WOMAC Pain Subscale Scores at Week 12Primary· 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.
Group
Value
95% CI
Placebo
-1.24
-1.71 – -0.77
Meloxicam 15 mg
-2.06
-2.53 – -1.58
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12Secondary· 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. C
Pain subscale (Week 2)
Group
Value
95% CI
Placebo
-0.76
-1.15 – -0.36
Meloxicam 15 mg
-1.12
-1.52 – -0.73
Pain subscale (Week 4)
Group
Value
95% CI
Placebo
-1.18
-1.60 – -0.76
Meloxicam 15 mg
-1.53
-1.95 – -1.11
Pain subscale (Week 8)
Group
Value
95% CI
Placebo
-1.31
-1.74 – -0.87
Meloxicam 15 mg
-1.82
-2.26 – -1.39
Pain subscale (Week 12)
Group
Value
95% CI
Placebo
-1.24
-1.71 – -0.77
Meloxicam 15 mg
-2.06
-2.53 – -1.58
Stiffness subscale (Week 2)
Group
Value
95% CI
Placebo
-0.78
-1.16 – -0.39
Meloxicam 15 mg
-1.11
-1.49 – -0.72
Stiffness subscale (Week 4)
Group
Value
95% CI
Placebo
-1.14
-1.58 – -0.71
Meloxicam 15 mg
-1.34
-1.78 – -0.90
Stiffness subscale (Week 8)
Group
Value
95% CI
Placebo
-1.23
-1.66 – -0.79
Meloxicam 15 mg
-1.70
-2.14 – -1.25
Stiffness subscale (Week 12)
Group
Value
95% CI
Placebo
-1.20
-1.67 – -0.72
Meloxicam 15 mg
-1.86
-2.34 – -1.39
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12Secondary· 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.
Walking on flat surface (Week 2)
Group
Value
95% CI
Placebo
-0.51
-0.92 – -0.10
Meloxicam 15 mg
-1.13
-1.54 – -0.71
Walking on flat surface (Week 4)
Group
Value
95% CI
Placebo
-1.04
-1.50 – -0.59
Meloxicam 15 mg
-1.61
-2.07 – -1.15
Walking on flat surface (Week 8)
Group
Value
95% CI
Placebo
-1.17
-1.63 – -0.71
Meloxicam 15 mg
-1.87
-2.33 – -1.41
Walking on flat surface (Week 12)
Group
Value
95% CI
Placebo
-1.05
-1.53 – -0.56
Meloxicam 15 mg
-1.97
-2.46 – -1.48
Going up or down stairs (Week 2)
Group
Value
95% CI
Placebo
-1.00
-1.40 – -0.60
Meloxicam 15 mg
-1.35
-1.75 – -0.94
Going up or down stairs (Week 4)
Group
Value
95% CI
Placebo
-1.34
-1.76 – -0.93
Meloxicam 15 mg
-1.74
-2.16 – -1.32
Going up or down stairs (Week 8)
Group
Value
95% CI
Placebo
-1.53
-2.00 – -1.07
Meloxicam 15 mg
-2.09
-2.55 – -1.62
Going up or down stairs (Week 12)
Group
Value
95% CI
Placebo
-1.34
-1.83 – -0.86
Meloxicam 15 mg
-2.43
-2.91 – -1.94
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12Secondary· 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%).
>0% reduction
Group
Value
95% CI
Placebo
53.1
Meloxicam 15 mg
75.7
Greater than or equal to (>=) 10% reduction
Group
Value
95% CI
Placebo
46.2
Meloxicam 15 mg
67.4
>=20% reduction
Group
Value
95% CI
Placebo
37.1
Meloxicam 15 mg
58.3
>=30% reduction
Group
Value
95% CI
Placebo
29.4
Meloxicam 15 mg
49.3
>=40% reduction
Group
Value
95% CI
Placebo
22.4
Meloxicam 15 mg
43.8
>=50% reduction
Group
Value
95% CI
Placebo
16.1
Meloxicam 15 mg
34.0
>=60% reduction
Group
Value
95% CI
Placebo
10.5
Meloxicam 15 mg
24.3
>=70% reduction
Group
Value
95% CI
Placebo
7.7
Meloxicam 15 mg
12.5
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12Secondary· 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.
>=30% reduction (Week 2)
Group
Value
95% CI
Placebo
17.48
Meloxicam 15 mg
22.92
>=30% reduction (Week 4)
Group
Value
95% CI
Placebo
30.07
Meloxicam 15 mg
36.81
>=30% reduction (Week 8)
Group
Value
95% CI
Placebo
34.97
Meloxicam 15 mg
45.14
>=30% reduction (Week 12)
Group
Value
95% CI
Placebo
29.37
Meloxicam 15 mg
49.31
>=50% reduction (Week 2)
Group
Value
95% CI
Placebo
4.90
Meloxicam 15 mg
9.03
>=50% reduction (Week 4)
Group
Value
95% CI
Placebo
9.09
Meloxicam 15 mg
14.58
>=50% reduction (Week 8)
Group
Value
95% CI
Placebo
13.29
Meloxicam 15 mg
24.31
>=50% reduction (Week 12)
Group
Value
95% CI
Placebo
16.08
Meloxicam 15 mg
34.03
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12Secondary· 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.
Week 2
Group
Value
95% CI
Placebo
-0.27
-0.39 – -0.15
Meloxicam 15 mg
-0.45
-0.57 – -0.33
Week 4
Group
Value
95% CI
Placebo
-0.37
-0.50 – -0.23
Meloxicam 15 mg
-0.53
-0.66 – -0.39
Week 8
Group
Value
95% CI
Placebo
-0.34
-0.46 – -0.23
Meloxicam 15 mg
-0.52
-0.64 – -0.40
Week 12
Group
Value
95% CI
Placebo
-0.43
-0.58 – -0.28
Meloxicam 15 mg
-0.62
-0.78 – -0.47
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12Secondary· 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.
Week 2
Group
Value
95% CI
Placebo
2.80
Meloxicam 15 mg
4.86
Week 4
Group
Value
95% CI
Placebo
6.29
Meloxicam 15 mg
11.81
Week 8
Group
Value
95% CI
Placebo
5.59
Meloxicam 15 mg
6.25
Week 12
Group
Value
95% CI
Placebo
8.39
Meloxicam 15 mg
13.19
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12Secondary· 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 me
General health
Group
Value
95% CI
Placebo
4.60
1.93 – 7.28
Meloxicam 15 mg
5.98
3.29 – 8.67
Physical functioning
Group
Value
95% CI
Placebo
6.95
3.73 – 10.16
Meloxicam 15 mg
12.88
9.65 – 16.12
Role physical
Group
Value
95% CI
Placebo
5.79
1.74 – 9.84
Meloxicam 15 mg
13.95
9.89 – 18.02
Bodily pain
Group
Value
95% CI
Placebo
7.51
4.44 – 10.58
Meloxicam 15 mg
14.87
11.78 – 17.96
Vitality
Group
Value
95% CI
Placebo
5.03
2.56 – 7.50
Meloxicam 15 mg
7.08
4.61 – 9.55
Social functioning
Group
Value
95% CI
Placebo
6.06
2.60 – 9.51
Meloxicam 15 mg
12.02
8.55 – 15.49
Role emotional
Group
Value
95% CI
Placebo
4.65
0.26 – 9.04
Meloxicam 15 mg
10.52
6.11 – 14.93
Mental health
Group
Value
95% CI
Placebo
4.50
2.13 – 6.87
Meloxicam 15 mg
5.07
2.71 – 7.43
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 31 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01430559.