Osteo Arthritis Knee
Conditions
Keywords
Osteoarthritis, Pain, Osteoarthritis Knee
Brief summary
The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
Interventions
DRUGV120083
Capsules
DRUGNaproxen
Capsules
DRUGPlacebo
Capsules to match V120083 and/or naproxen
Sponsors
Shionogi
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria Include: 1. Males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic OA pain of the knee (lasting several hours daily) as their predominant pain condition for at least 6 months prior to screening 2. Diagnostic criteria for primary pain condition (American College of Rheumatology \[ACR\] clinical and radiographic criteria): * At least 1 of the following in addition to knee pain: age \> 50, morning stiffness \< 30 minutes, crepitus on active motion, and * Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit as determined by a local radiologist or rheumatologist. If a radiograph is not available, one must be taken and the diagnostic criteria must be confirmed before randomization. 3. Subjects whose OA pain of the index knee is not adequately treated prior to the screening visit: * Subjects must have a self-reported average pain intensity rating of moderate or severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7 days prior to the screening visit 4. The subjects must have average pain over the last 24 hours scores ≥ 4 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry 5. Subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for OA pain for the duration of the study, with the exception of study-specific rescue medication. Key
Exclusion criteria
Include: 1. Subjects with radiographic evidence of OA with K-L grade 0,1 or 4 2. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area 3. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period 4. Subjects with a history of a prior joint replacement of the index knee 5. Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study 6. Subjects with a history of significant trauma to a knee, hip or shoulder within the previous year 7. Subjects who have significant pain, other than or more than knee pain, including significant hip, back pain, that may confound the analgesic efficacy assessments of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Average Pain Over the Last 24 Hours Score at Week 4 | Week 4 | At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Pain Right Now Score Collected by e-Diary | 4 Weeks | Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine. |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | 4 Weeks | The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20. |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | 4 Weeks | The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8. |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | 4 Weeks | The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68. |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | 4 Weeks | The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96. |
| Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | 4 Weeks | The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110. |
| Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | 4 Weeks | The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10. |
| Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | 4 Weeks | The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10. |
| Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Weeks 1, 2 and 4 | Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine. |
| Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | 4 Weeks | The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state. |
| Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | 4 Weeks | The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state. |
| European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | 4 Weeks | EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Patient Global Impression of Change (PGIC) | 4 Weeks | The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding very much improved and much improved was summarized by treatment group. |
| Supplemental Analgesic Medication Use | Up to 28 days | The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group. |
| Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Baseline up to 4 Weeks | Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment. |
| Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 | Safety assessment to evaluate the impact of V120083 on mood (anxiety \[HADS-A\] and depression \[HADS-D\]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder. |
| Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Week 4 | A subject's response to treatment was defined as the percentage reduction from the baseline average pain over the last 24 hours score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having \> 0 % reduction; non-responders were defined as having ≤ 0% reduction. |
Countries
United States
Participant flow
Recruitment details
First subject first visit: 14-Mar-2017; last subject last visit: 21-Nov-2017. Thirty-one investigative centers in the United States participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| V120083 30 mg V120083 30 mg taken orally twice daily | 74 |
| V120083 60 mg V120083 60 mg taken orally twice daily | 67 |
| Naproxen Naproxen 500 mg taken orally twice daily | 76 |
| Placebo To match V120083 and/or naproxen taken orally twice daily | 74 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative | 5 | 5 | 12 | 4 |
| Overall Study | Adverse Event | 7 | 4 | 3 | 3 |
| Overall Study | Lack of Efficacy | 3 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | V120083 30 mg | V120083 60 mg | Naproxen | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 8.66 | 60.7 years STANDARD_DEVIATION 8.62 | 59.8 years STANDARD_DEVIATION 8.94 | 59.0 years STANDARD_DEVIATION 8.97 | 60.1 years STANDARD_DEVIATION 8.79 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 18 Participants | 14 Participants | 19 Participants | 70 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 48 Participants | 61 Participants | 54 Participants | 214 Participants |
| Sex: Female, Male Female | 46 Participants | 42 Participants | 49 Participants | 46 Participants | 183 Participants |
| Sex: Female, Male Male | 28 Participants | 25 Participants | 27 Participants | 28 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 67 | 0 / 76 | 0 / 74 |
| other Total, other adverse events | 18 / 74 | 20 / 67 | 17 / 76 | 11 / 74 |
| serious Total, serious adverse events | 0 / 74 | 1 / 67 | 1 / 76 | 0 / 74 |
Outcome results
Primary
Daily Average Pain Over the Last 24 Hours Score at Week 4
At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Time frame: Week 4
Population: The full analysis population (FAP) (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Week 4 | 4.2 score on a scale | Standard Error 0.28 |
| V120083 30 mg | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Baseline | 5.9 score on a scale | Standard Error 0.2 |
| V120083 60 mg | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Week 4 | 4.3 score on a scale | Standard Error 0.28 |
| V120083 60 mg | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Baseline | 5.9 score on a scale | Standard Error 0.18 |
| Naproxen | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Baseline | 6.1 score on a scale | Standard Error 0.16 |
| Naproxen | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Week 4 | 3.6 score on a scale | Standard Error 0.26 |
| Placebo | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Week 4 | 4.4 score on a scale | Standard Error 0.29 |
| Placebo | Daily Average Pain Over the Last 24 Hours Score at Week 4 | Baseline | 5.9 score on a scale | Standard Error 0.21 |
Secondary
Average Daily Pain Right Now Score Collected by e-Diary
Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Average Daily Pain Right Now Score Collected by e-Diary | Baseline | 6.104 score on a scale | Standard Error 0.1851 |
| V120083 30 mg | Average Daily Pain Right Now Score Collected by e-Diary | Week 4 | 6.366 score on a scale | Standard Error 0.64 |
| V120083 60 mg | Average Daily Pain Right Now Score Collected by e-Diary | Week 4 | 7.269 score on a scale | Standard Error 0.2627 |
| V120083 60 mg | Average Daily Pain Right Now Score Collected by e-Diary | Baseline | 6.737 score on a scale | Standard Error 0.2076 |
| Naproxen | Average Daily Pain Right Now Score Collected by e-Diary | Baseline | 6.590 score on a scale | Standard Error 0.2223 |
| Naproxen | Average Daily Pain Right Now Score Collected by e-Diary | Week 4 | 6.000 score on a scale | — |
| Placebo | Average Daily Pain Right Now Score Collected by e-Diary | Baseline | 6.481 score on a scale | Standard Error 0.2587 |
| Placebo | Average Daily Pain Right Now Score Collected by e-Diary | Week 4 | 5.833 score on a scale | Standard Error 0.7318 |
Secondary
Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
Safety assessment to evaluate the impact of V120083 on mood (anxiety \[HADS-A\] and depression \[HADS-D\]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.
Time frame: Week 4
Population: The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-A | -0.5 score on a scale | Standard Error 0.26 |
| V120083 30 mg | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-D | 0.3 score on a scale | Standard Error 0.25 |
| V120083 60 mg | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-D | 0.6 score on a scale | Standard Error 0.31 |
| V120083 60 mg | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-A | -0.3 score on a scale | Standard Error 0.26 |
| Naproxen | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-A | -0.4 score on a scale | Standard Error 0.3 |
| Naproxen | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-D | -0.2 score on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-A | -0.6 score on a scale | Standard Error 0.35 |
| Placebo | Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score | Week 4 change from baseline - HADS-D | -0.1 score on a scale | Standard Error 0.3 |
Secondary
European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Baseline VAS Score | 73.2 score on a scale | Standard Error 2.04 |
| V120083 30 mg | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Week 4 VAS Score | 77.0 score on a scale | Standard Error 2.17 |
| V120083 60 mg | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Week 4 VAS Score | 77.4 score on a scale | Standard Error 2.42 |
| V120083 60 mg | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Baseline VAS Score | 72.9 score on a scale | Standard Error 1.94 |
| Naproxen | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Baseline VAS Score | 75.4 score on a scale | Standard Error 1.88 |
| Naproxen | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Week 4 VAS Score | 83.7 score on a scale | Standard Error 1.37 |
| Placebo | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Baseline VAS Score | 74.6 score on a scale | Standard Error 1.79 |
| Placebo | European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status | Week 4 VAS Score | 81.4 score on a scale | Standard Error 1.43 |
Secondary
Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Baseline | 59.248 score on a scale | Standard Error 0.9688 |
| V120083 30 mg | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Week 4 | 59.596 score on a scale | Standard Error 0.9615 |
| V120083 60 mg | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Week 4 | 59.560 score on a scale | Standard Error 1.0785 |
| V120083 60 mg | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Baseline | 59.766 score on a scale | Standard Error 1.1498 |
| Naproxen | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Baseline | 60.450 score on a scale | Standard Error 0.8714 |
| Naproxen | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Week 4 | 60.921 score on a scale | Standard Error 0.7819 |
| Placebo | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Baseline | 59.450 score on a scale | Standard Error 1.0132 |
| Placebo | Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary | Week 4 | 60.948 score on a scale | Standard Error 0.8835 |
Secondary
Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Baseline | 31.689 score on a scale | Standard Error 0.9696 |
| V120083 30 mg | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Week 4 | 35.515 score on a scale | Standard Error 1.3008 |
| V120083 60 mg | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Week 4 | 36.277 score on a scale | Standard Error 1.3584 |
| V120083 60 mg | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Baseline | 31.629 score on a scale | Standard Error 0.9146 |
| Naproxen | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Week 4 | 39.372 score on a scale | Standard Error 1.2486 |
| Naproxen | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Baseline | 32.348 score on a scale | Standard Error 1.0737 |
| Placebo | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Week 4 | 37.826 score on a scale | Standard Error 1.144 |
| Placebo | Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Baseline | 33.762 score on a scale | Standard Error 1.0315 |
Secondary
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Baseline | 4.618 score on a scale | Standard Error 0.2717 |
| V120083 30 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Week 4 | 2.847 score on a scale | Standard Error 0.2925 |
| V120083 60 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Week 4 | 2.679 score on a scale | Standard Error 0.2961 |
| V120083 60 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Baseline | 4.348 score on a scale | Standard Error 0.2573 |
| Naproxen | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Baseline | 4.718 score on a scale | Standard Error 0.2186 |
| Naproxen | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Week 4 | 2.070 score on a scale | Standard Error 0.2377 |
| Placebo | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Baseline | 4.278 score on a scale | Standard Error 0.2721 |
| Placebo | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Week 4 | 2.634 score on a scale | Standard Error 0.3049 |
Secondary
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Baseline | 5.784 score on a scale | Standard Error 0.2068 |
| V120083 30 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Week 4 | 4.139 score on a scale | Standard Error 0.284 |
| V120083 60 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Baseline | 5.739 score on a scale | Standard Error 0.1935 |
| V120083 60 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Week 4 | 4.135 score on a scale | Standard Error 0.2771 |
| Naproxen | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Baseline | 5.747 score on a scale | Standard Error 0.1525 |
| Naproxen | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Week 4 | 3.510 score on a scale | Standard Error 0.2543 |
| Placebo | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Week 4 | 4.308 score on a scale | Standard Error 0.29 |
| Placebo | Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Baseline | 5.801 score on a scale | Standard Error 0.1978 |
Secondary
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.
Time frame: 4 Weeks
Population: The FAP (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Baseline | 55.5 score on a scale | Standard Error 2.49 |
| V120083 30 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Week 4 | 36.5 score on a scale | Standard Error 2.97 |
| V120083 60 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Week 4 | 35.3 score on a scale | Standard Error 3.03 |
| V120083 60 mg | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Baseline | 53.4 score on a scale | Standard Error 2.3 |
| Naproxen | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Baseline | 56.0 score on a scale | Standard Error 1.9 |
| Naproxen | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Week 4 | 28.5 score on a scale | Standard Error 2.51 |
| Placebo | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Baseline | 53.1 score on a scale | Standard Error 2.5 |
| Placebo | Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) | Week 4 | 35.7 score on a scale | Standard Error 3.14 |
Secondary
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.
Time frame: Baseline up to 4 Weeks
Population: The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V120083 30 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation or behavior | 0 Participants |
| V120083 30 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal behavior | 0 Participants |
| V120083 30 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation | 0 Participants |
| V120083 30 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Self-injurious behavior without suicidal intent | 0 Participants |
| V120083 60 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal behavior | 0 Participants |
| V120083 60 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation | 0 Participants |
| V120083 60 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation or behavior | 0 Participants |
| V120083 60 mg | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Self-injurious behavior without suicidal intent | 0 Participants |
| Naproxen | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation | 0 Participants |
| Naproxen | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Self-injurious behavior without suicidal intent | 0 Participants |
| Naproxen | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation or behavior | 0 Participants |
| Naproxen | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal behavior | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal behavior | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Self-injurious behavior without suicidal intent | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) | Suicidal ideation or behavior | 0 Participants |
Secondary
Patient Global Impression of Change (PGIC)
The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding very much improved and much improved was summarized by treatment group.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V120083 30 mg | Patient Global Impression of Change (PGIC) | Total Subjects Completing PGIC | 72 Participants |
| V120083 30 mg | Patient Global Impression of Change (PGIC) | Subjects Responding 'Very Much' / 'Much' Improved | 25 Participants |
| V120083 60 mg | Patient Global Impression of Change (PGIC) | Subjects Responding 'Very Much' / 'Much' Improved | 27 Participants |
| V120083 60 mg | Patient Global Impression of Change (PGIC) | Total Subjects Completing PGIC | 65 Participants |
| Naproxen | Patient Global Impression of Change (PGIC) | Total Subjects Completing PGIC | 76 Participants |
| Naproxen | Patient Global Impression of Change (PGIC) | Subjects Responding 'Very Much' / 'Much' Improved | 38 Participants |
| Placebo | Patient Global Impression of Change (PGIC) | Total Subjects Completing PGIC | 72 Participants |
| Placebo | Patient Global Impression of Change (PGIC) | Subjects Responding 'Very Much' / 'Much' Improved | 18 Participants |
Secondary
Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4
A subject's response to treatment was defined as the percentage reduction from the baseline average pain over the last 24 hours score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having \> 0 % reduction; non-responders were defined as having ≤ 0% reduction.
Time frame: Week 4
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V120083 30 mg | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - Yes | 46 Participants |
| V120083 30 mg | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - No | 28 Participants |
| V120083 60 mg | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - No | 25 Participants |
| V120083 60 mg | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - Yes | 42 Participants |
| Naproxen | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - Yes | 57 Participants |
| Naproxen | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - No | 19 Participants |
| Placebo | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - Yes | 42 Participants |
| Placebo | Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4 | Responder - No | 32 Participants |
Secondary
Supplemental Analgesic Medication Use
The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.
Time frame: Up to 28 days
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| V120083 30 mg | Supplemental Analgesic Medication Use | 0.779 Supplemental Analgesic Tablets | Standard Error 0.1471 |
| V120083 60 mg | Supplemental Analgesic Medication Use | 0.686 Supplemental Analgesic Tablets | Standard Error 0.1187 |
| Naproxen | Supplemental Analgesic Medication Use | 0.378 Supplemental Analgesic Tablets | Standard Error 0.0712 |
| Placebo | Supplemental Analgesic Medication Use | 0.670 Supplemental Analgesic Tablets | Standard Error 0.1205 |
Secondary
Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale
Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Time frame: Weeks 1, 2 and 4
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 4 change from baseline | -1.959 score on a scale | Standard Error 0.2553 |
| V120083 30 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 1 change from baseline | -0.920 score on a scale | Standard Error 0.1721 |
| V120083 30 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 2 change from baseline | -1.653 score on a scale | Standard Error 0.2087 |
| V120083 30 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Baseline | 6.242 score on a scale | Standard Error 0.153 |
| V120083 60 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 2 change from baseline | -1.336 score on a scale | Standard Error 0.1998 |
| V120083 60 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Baseline | 6.431 score on a scale | Standard Error 0.1408 |
| V120083 60 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 1 change from baseline | -0.860 score on a scale | Standard Error 0.1405 |
| V120083 60 mg | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 4 change from baseline | -1.803 score on a scale | Standard Error 0.2957 |
| Naproxen | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Baseline | 6.469 score on a scale | Standard Error 0.1426 |
| Naproxen | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 1 change from baseline | -1.655 score on a scale | Standard Error 0.1789 |
| Naproxen | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 2 change from baseline | -2.255 score on a scale | Standard Error 0.2443 |
| Naproxen | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 4 change from baseline | -2.741 score on a scale | Standard Error 0.2898 |
| Placebo | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Baseline | 6.543 score on a scale | Standard Error 0.1497 |
| Placebo | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 4 change from baseline | -1.952 score on a scale | Standard Error 0.2667 |
| Placebo | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 1 change from baseline | -0.977 score on a scale | Standard Error 0.1569 |
| Placebo | Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale | Week 2 change from baseline | -1.593 score on a scale | Standard Error 0.1979 |
Secondary
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Week 4 | 7.0 score on a scale | Standard Error 0.5 |
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Baseline | 10.2 score on a scale | Standard Error 0.4 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Week 4 | 7.2 score on a scale | Standard Error 0.48 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Baseline | 9.6 score on a scale | Standard Error 0.34 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Week 4 | 5.5 score on a scale | Standard Error 0.41 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Baseline | 9.9 score on a scale | Standard Error 0.34 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Week 4 | 6.8 score on a scale | Standard Error 0.46 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Baseline | 10.1 score on a scale | Standard Error 0.38 |
Secondary
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Baseline | 34.6 score on a scale | Standard Error 1.23 |
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Week 4 | 25.6 score on a scale | Standard Error 1.73 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Week 4 | 25.0 score on a scale | Standard Error 1.79 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Baseline | 34.8 score on a scale | Standard Error 1.13 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Week 4 | 18.7 score on a scale | Standard Error 1.46 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Baseline | 33.6 score on a scale | Standard Error 1.19 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Week 4 | 23.2 score on a scale | Standard Error 1.64 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Baseline | 35.1 score on a scale | Standard Error 1.23 |
Secondary
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Baseline | 4.6 score on a scale | Standard Error 0.17 |
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Week 4 | 3.2 score on a scale | Standard Error 0.2 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Week 4 | 3.3 score on a scale | Standard Error 0.24 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Baseline | 4.5 score on a scale | Standard Error 0.18 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Baseline | 4.2 score on a scale | Standard Error 0.17 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Week 4 | 2.6 score on a scale | Standard Error 0.19 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Baseline | 4.5 score on a scale | Standard Error 0.17 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Week 4 | 3.1 score on a scale | Standard Error 0.2 |
Secondary
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.
Time frame: 4 Weeks
Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Baseline | 49.3 score on a scale | Standard Error 1.67 |
| V120083 30 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Week 4 | 35.8 score on a scale | Standard Error 2.35 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Week 4 | 35.5 score on a scale | Standard Error 2.45 |
| V120083 60 mg | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Baseline | 48.9 score on a scale | Standard Error 1.54 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Week 4 | 26.8 score on a scale | Standard Error 1.99 |
| Naproxen | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Baseline | 47.6 score on a scale | Standard Error 1.55 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Baseline | 49.6 score on a scale | Standard Error 1.65 |
| Placebo | Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Week 4 | 33.1 score on a scale | Standard Error 2.25 |