Osteoarthritis of the Knee
Conditions
Keywords
Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee
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.
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
Interventions
DRUGMeloxicam
7.5mg x2 once a day for 12 weeks
DRUGPlacebo
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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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%). |
| 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. |
| 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. |
Countries
China
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks. | 143 |
| Meloxicam 15 mg Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks. | 144 |
| Total | 287 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 3 |
| Overall Study | Entry criteria not met | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Medication error | 1 | 0 |
| Overall Study | Other | 3 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Randomized, Not Treated | 3 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Meloxicam 15 mg | Total |
|---|---|---|---|
| Age, Customized 26 to 35 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 36 to 45 years | 4 Participants | 12 Participants | 16 Participants |
| Age, Customized 46 to 55 years | 43 Participants | 44 Participants | 87 Participants |
| Age, Customized 56 to 65 years | 61 Participants | 60 Participants | 121 Participants |
| Age, Customized 66 to 75 years | 34 Participants | 27 Participants | 61 Participants |
| Sex: Female, Male Female | 106 Participants | 122 Participants | 228 Participants |
| Sex: Female, Male Male | 37 Participants | 22 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 143 | 0 / 144 | 0 / 63 | 0 / 6 | 0 / 52 |
| serious Total, serious adverse events | 2 / 143 | 0 / 144 | 0 / 63 | 0 / 6 | 0 / 52 |
Outcome results
Primary
Change From Baseline in WOMAC Pain Subscale Scores at 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.
Time frame: Baseline and Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OA Participants | Change From Baseline in WOMAC Pain Subscale Scores at Week 12 | -1.24 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Scores at Week 12 | -2.06 units on a scale |
p-value: <0.000195% CI: [-1.2, -0.43]ANCOVA
Primary
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)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OA Participants | 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) | Pain subscale (paper worksheet) | 5.7 units on a scale | Standard Deviation 1.47 |
| OA Participants | 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) | Stiffness subscale (paper worksheet) | 5.3 units on a scale | Standard Deviation 1.94 |
| OA Participants | 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) | Physical function subscale (paper worksheet) | 5.7 units on a scale | Standard Deviation 1.56 |
| OA Participants | 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) | Total (paper worksheet) | 135.9 units on a scale | Standard Deviation 35.59 |
| OA Participants | 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) | Pain subscale (e-dary) | 5.7 units on a scale | Standard Deviation 1.47 |
| OA Participants | 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) | Stiffness subscale (e-diary) | 5.3 units on a scale | Standard Deviation 2 |
| OA Participants | 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) | Physical function subscale (e-diary) | 5.7 units on a scale | Standard Deviation 1.56 |
| OA Participants | 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) | Total (e-diary) | 136.0 units on a scale | Standard Deviation 35.92 |
| Healthy Participants | 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) | Total (e-diary) | 0.8 units on a scale | Standard Deviation 3.66 |
| Healthy Participants | 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) | Pain subscale (e-dary) | 0.1 units on a scale | Standard Deviation 0.22 |
| Healthy Participants | 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) | Physical function subscale (e-diary) | 0.0 units on a scale | Standard Deviation 0.14 |
| Healthy Participants | 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) | Stiffness subscale (e-diary) | 0.1 units on a scale | Standard Deviation 0.31 |
Primary
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Pain subscale score | 6.0 units on a scale | Standard Deviation 1.29 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Stiffness subscale score | 5.7 units on a scale | Standard Deviation 1.56 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Physical function subscale score | 6.1 units on a scale | Standard Deviation 1.32 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Total score | 145.0 units on a scale | Standard Deviation 31.05 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Total score | 144.8 units on a scale | Standard Deviation 29.57 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Pain subscale score | 6.0 units on a scale | Standard Deviation 1.32 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Physical function subscale score | 6.1 units on a scale | Standard Deviation 1.22 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary | Stiffness subscale score | 5.6 units on a scale | Standard Deviation 1.65 |
Primary
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary
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)
Population: VAS: all OA participants who were non-screen failure at Visit 1 (Screening 1) and returned for Visit 2 (Screening 2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary | Pain subscale score | 5.6 units on a scale | Standard Deviation 1.46 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary | Stiffness subscale score | 5.4 units on a scale | Standard Deviation 1.76 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary | Physical function subscale score | 5.8 units on a scale | Standard Deviation 1.52 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary | Total score | 136.6 units on a scale | Standard Deviation 35.38 |
Primary
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Pain subscale score | 4.4 units on a scale | Standard Deviation 2.05 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Stiffness subscale score | 4.2 units on a scale | Standard Deviation 2.26 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Physical function subscale score | 4.5 units on a scale | Standard Deviation 2.08 |
| OA Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Total score | 106.6 units on a scale | Standard Deviation 49.7 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Total score | 88.7 units on a scale | Standard Deviation 44.45 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Pain subscale score | 3.6 units on a scale | Standard Deviation 1.9 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Physical function subscale score | 3.7 units on a scale | Standard Deviation 1.87 |
| Healthy Participants | WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary | Stiffness subscale score | 3.5 units on a scale | Standard Deviation 1.96 |
Secondary
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at 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.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| OA Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 2 | -0.27 units on a scale |
| OA Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 4 | -0.37 units on a scale |
| OA Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 8 | -0.34 units on a scale |
| OA Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 12 | -0.43 units on a scale |
| Healthy Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 12 | -0.62 units on a scale |
| Healthy Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 2 | -0.45 units on a scale |
| Healthy Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 8 | -0.52 units on a scale |
| Healthy Participants | Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 | Week 4 | -0.53 units on a scale |
Comparison: Week 2p-value: 0.002795% CI: [-0.31, -0.07]ANCOVA
Comparison: Week 4p-value: 0.030895% CI: [-0.3, -0.01]ANCOVA
Comparison: Week 8p-value: 0.00695% CI: [-0.31, -0.05]ANCOVA
Comparison: Week 12p-value: 0.007695% CI: [-0.34, -0.05]ANCOVA
Secondary
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at 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.
Time frame: Baseline and Week 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | General health | 4.60 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Physical functioning | 6.95 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Role physical | 5.79 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Bodily pain | 7.51 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Vitality | 5.03 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Social functioning | 6.06 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Role emotional | 4.65 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Mental health | 4.50 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Mental component aggregate | 2.19 units on a scale |
| OA Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Physical component aggregate | 2.65 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Mental health | 5.07 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | General health | 5.98 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Social functioning | 12.02 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Physical functioning | 12.88 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Physical component aggregate | 5.21 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Role physical | 13.95 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Role emotional | 10.52 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Bodily pain | 14.87 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Mental component aggregate | 3.14 units on a scale |
| Healthy Participants | Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 | Vitality | 7.08 units on a scale |
Comparison: General healthp-value: 0.373895% CI: [-1.67, 4.42]ANCOVA
Comparison: Physical functioningp-value: 0.002895% CI: [2.07, 9.8]ANCOVA
Comparison: Role physicalp-value: 0.000295% CI: [3.95, 12.38]ANCOVA
Comparison: Bodily painp-value: <0.000195% CI: [4.1, 10.63]ANCOVA
Comparison: Vitalityp-value: 0.212495% CI: [-1.18, 5.27]ANCOVA
Comparison: Social functioningp-value: 0.00595% CI: [1.82, 10.1]ANCOVA
Comparison: Role emotionalp-value: 0.009395% CI: [1.46, 10.28]ANCOVA
Comparison: Mental healthp-value: 0.727495% CI: [-2.66, 3.81]ANCOVA
Comparison: Mental component aggregatep-value: 0.281995% CI: [-0.78, 2.67]ANCOVA
Comparison: Physical component aggregatep-value: 0.000195% CI: [1.27, 3.86]ANCOVA
Secondary
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
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| OA Participants | 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 | Week 2 | -0.67 units on a scale |
| OA Participants | 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 | Week 4 | -1.11 units on a scale |
| OA Participants | 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 | Week 8 | -1.31 units on a scale |
| OA Participants | 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 | Week 12 | -1.43 units on a scale |
| Healthy Participants | 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 | Week 12 | -2.06 units on a scale |
| Healthy Participants | 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 | Week 2 | -0.97 units on a scale |
| Healthy Participants | 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 | Week 8 | -1.76 units on a scale |
| Healthy Participants | 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 | Week 4 | -1.42 units on a scale |
Comparison: Week 2p-value: 0.036795% CI: [-0.58, -0.02]ANCOVA
Comparison: Week 4p-value: 0.065295% CI: [-0.65, 0.02]ANCOVA
Comparison: Week 8p-value: 0.0295% CI: [-0.81, -0.07]ANCOVA
Comparison: Week 12p-value: 0.001695% CI: [-1.02, -0.24]ANCOVA
Secondary
Change From Baseline in WOMAC Pain Subscale Items at 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.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 2) | -0.51 units on a scale |
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 4) | -1.04 units on a scale |
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 8) | -1.17 units on a scale |
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 12) | -1.05 units on a scale |
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 2) | -1.00 units on a scale |
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 4) | -1.34 units on a scale |
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 8) | -1.53 units on a scale |
| OA Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 12) | -1.34 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 12) | -2.43 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 2) | -1.13 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 2) | -1.35 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 4) | -1.61 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 8) | -2.09 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 8) | -1.87 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Going up or down stairs (Week 4) | -1.74 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 | Walking on flat surface (Week 12) | -1.97 units on a scale |
Comparison: Walking on flat surface (Week 2)p-value: 0.000295% CI: [-0.94, -0.3]ANCOVA
Comparison: Walking on flat surface (Week 4)p-value: 0.001595% CI: [-0.92, -0.22]ANCOVA
Comparison: Walking on flat surface (Week 8)p-value: 0.000395% CI: [-1.08, -0.32]ANCOVA
Comparison: Walking on flat surface (Week 12)p-value: <0.000195% CI: [-1.34, -0.51]ANCOVA
Comparison: Going up or down stairs (Week 2)p-value: 0.036395% CI: [-0.67, -0.02]ANCOVA
Comparison: Going up or down stairs (Week 4)p-value: 0.031195% CI: [-0.75, -0.04]ANCOVA
Comparison: Going up or down stairs (Week 8)p-value: 0.005795% CI: [-0.94, -0.16]ANCOVA
Comparison: Going up or down stairs (Week 12)p-value: <0.000195% CI: [-1.52, -0.64]ANCOVA
Secondary
Change From Baseline in WOMAC Subscale and Average Scores at 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.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 8) | -1.29 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 12) | -1.23 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 2) | -0.76 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 4) | -1.18 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 8) | -1.31 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 12) | -1.24 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 2) | -0.78 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 4) | -1.14 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 8) | -1.23 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 12) | -1.20 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 2) | -0.77 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 4) | -1.18 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 8) | -1.31 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 12) | -1.25 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 2) | -0.77 units on a scale |
| OA Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 4) | -1.17 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 4) | -1.47 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 8) | -1.78 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 8) | -1.70 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 12) | -2.00 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 8) | -1.82 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 2) | -1.12 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 12) | -1.86 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 4) | -1.53 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Average score (Week 2) | -1.15 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 8) | -1.82 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 2) | -1.21 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Pain subscale (Week 12) | -2.06 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 12) | -2.06 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 2) | -1.11 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Physical function subscale (Week 4) | -1.53 units on a scale |
| Healthy Participants | Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 | Stiffness subscale (Week 4) | -1.34 units on a scale |
Comparison: Pain subscale (Week 2)p-value: 0.010395% CI: [-0.65, -0.09]ANCOVA
Comparison: Pain subscale (Week 4)p-value: 0.029595% CI: [-0.67, -0.04]ANCOVA
Comparison: Pain subscale (Week 8)p-value: 0.004195% CI: [-0.87, -0.17]ANCOVA
Comparison: Pain subscale (Week 12)p-value: <0.000195% CI: [-1.2, -0.43]ANCOVA
Comparison: Stiffness subscale (Week 2)p-value: 0.036995% CI: [-0.64, -0.02]ANCOVA
Comparison: Stiffness subscale (Week 4)p-value: 0.264295% CI: [-0.54, 0.15]ANCOVA
Comparison: Stiffness subscale (Week 8)p-value: 0.01495% CI: [-0.84, -0.1]ANCOVA
Comparison: Stiffness subscale (Week 12)p-value: 0.000995% CI: [-1.06, -0.28]ANCOVA
Comparison: Physical function subscale (Week 2)p-value: 0.001795% CI: [-0.72, -0.17]ANCOVA
Comparison: Physical function subscale (Week 4)p-value: 0.032895% CI: [-0.66, -0.03]ANCOVA
Comparison: Physical function subscale (Week 8)p-value: 0.004395% CI: [-0.86, -0.16]ANCOVA
Comparison: Physical function subscale (Week 12)p-value: <0.000195% CI: [-1.19, -0.43]ANCOVA
Comparison: Average score (Week 2)p-value: 0.005195% CI: [-0.65, -0.12]ANCOVA
Comparison: Average score (Week 4)p-value: 0.059395% CI: [-0.61, 0.01]ANCOVA
Comparison: Average score (Week 8)p-value: 0.004695% CI: [-0.84, -0.16]ANCOVA
Comparison: Average score (Week 12)p-value: <0.000195% CI: [-1.14, -0.39]ANCOVA
Secondary
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at 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.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OA Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | 2.80 percentage of participants |
| OA Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | 6.29 percentage of participants |
| OA Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | 5.59 percentage of participants |
| OA Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | 8.39 percentage of participants |
| Healthy Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | 13.19 percentage of participants |
| Healthy Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | 4.86 percentage of participants |
| Healthy Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | 6.25 percentage of participants |
| Healthy Participants | Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | 11.81 percentage of participants |
Comparison: Week 2p-value: 0.284395% CI: [0.53, 8.5]Regression, Logistic
Comparison: Week 4p-value: 0.10595% CI: [0.86, 4.87]Regression, Logistic
Comparison: Week 8p-value: 0.786195% CI: [0.4, 3.32]Regression, Logistic
Comparison: Week 12p-value: 0.187395% CI: [0.77, 3.78]Regression, Logistic
Secondary
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at 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.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 2) | 17.48 percentage of participants |
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 4) | 30.07 percentage of participants |
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 8) | 34.97 percentage of participants |
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 12) | 29.37 percentage of participants |
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 2) | 4.90 percentage of participants |
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 4) | 9.09 percentage of participants |
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 8) | 13.29 percentage of participants |
| OA Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 12) | 16.08 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 12) | 34.03 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 2) | 22.92 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 2) | 9.03 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 4) | 36.81 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 8) | 24.31 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 8) | 45.14 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=50% reduction (Week 4) | 14.58 percentage of participants |
| Healthy Participants | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 | >=30% reduction (Week 12) | 49.31 percentage of participants |
Comparison: \>=30% reduction (Week 2)p-value: 0.237395% CI: [0.79, 2.55]Regression, Logistic
Comparison: \>=30% reduction (Week 4)p-value: 0.206995% CI: [0.84, 2.26]Regression, Logistic
Comparison: \>=30% reduction (Week 8)p-value: 0.06895% CI: [0.97, 2.53]Regression, Logistic
Comparison: \>=30% reduction (Week 12)p-value: 0.000595% CI: [1.47, 3.94]Regression, Logistic
Comparison: \>=50% reduction (Week 2)p-value: 0.173695% CI: [0.75, 5.01]Regression, Logistic
Comparison: \>=50% reduction (Week 4)p-value: 0.149695% CI: [0.82, 3.59]Regression, Logistic
Comparison: \>=50% reduction (Week 8)p-value: 0.017195% CI: [1.14, 3.93]Regression, Logistic
Comparison: \>=50% reduction (Week 12)p-value: 0.000495% CI: [1.57, 4.89]Regression, Logistic
Secondary
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at 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.
Time frame: Baseline and Week 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by 0) | 79.7 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by -1) | 14.7 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by 0) | 67.8 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by -2) | 0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by -2) | 0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by 2) | 0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by -1) | 25.2 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by 1) | 2.1 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by 1) | 2.8 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by 0) | 77.6 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by -2) | 0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by -1) | 15.4 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by 2) | 0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by -2) | 1.4 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by 2) | 0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by 2) | 0.7 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by -1) | 14.0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by 1) | 7.7 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by 1) | 0.7 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by 0) | 72.0 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by 1) | 3.5 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by -1) | 14.7 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by 0) | 81.1 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by -2) | 1.4 percentage of participants |
| OA Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by 2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by -2) | 0.7 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by 2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by 1) | 0.7 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by 0) | 66.0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by -1) | 28.5 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Mobility (decrease by -2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by 2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by 1) | 4.2 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by 0) | 55.6 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by -1) | 35.4 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Self-care (decrease by -2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by 2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by 1) | 2.8 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by 0) | 63.2 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by -1) | 29.2 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Usual activities (decrease by -2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by 2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by 1) | 2.1 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by 0) | 67.4 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by -1) | 25.0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Pain/discomfort (decrease by -2) | 0.7 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by 2) | 0 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by 1) | 6.3 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by 0) | 67.4 percentage of participants |
| Healthy Participants | Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 | Anxiety/depression (decrease by -1) | 20.8 percentage of participants |
Comparison: Mobilityp-value: 0.001495% CI: [1.45, 4.66]Regression, Logistic
Comparison: Self-carep-value: 0.10895% CI: [0.91, 2.48]Regression, Logistic
Comparison: Usual activitiesp-value: 0.011995% CI: [1.17, 3.62]Regression, Logistic
Comparison: Pain/discomfortp-value: 0.088795% CI: [0.93, 2.83]Regression, Logistic
Comparison: Anxiety/depressionp-value: 0.246695% CI: [0.8, 2.33]Regression, Logistic
Secondary
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at 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%).
Time frame: Baseline and Week 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >0% reduction | 53.1 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | Greater than or equal to (>=) 10% reduction | 46.2 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=20% reduction | 37.1 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=30% reduction | 29.4 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=40% reduction | 22.4 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=50% reduction | 16.1 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=60% reduction | 10.5 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=70% reduction | 7.7 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=80% reduction | 4.2 percentage of participants |
| OA Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=90% reduction | 2.1 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=70% reduction | 12.5 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >0% reduction | 75.7 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=50% reduction | 34.0 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | Greater than or equal to (>=) 10% reduction | 67.4 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=90% reduction | 3.5 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=20% reduction | 58.3 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=60% reduction | 24.3 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=30% reduction | 49.3 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=80% reduction | 6.3 percentage of participants |
| Healthy Participants | Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 | >=40% reduction | 43.8 percentage of participants |