Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study |
HVLT-R: instrument consisting of 12 noun list, used to measure verbal learning and memory (recognition and recall). List was read to participant, who then attempted to recall as many words as possible. The examiner recorded each response. Task was repeated 2 more times, for total of 3 learning trials. After delay interval of 20-25 minutes, delayed recall trial was administered. Total score (TS) = sum of 3 learning trial scores of 12 word each, ranged: 0 (no memory) to 36 (best memory), where higher scores indicated better memory. Delayed recall (DR) = number of words recalled in delayed recall test, ranged: 0 (no memory) to 12 (best memory), where higher scores indicated better memory. |
A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of Study (12 weeks after the last dose of study drug) |
|
| Primary |
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events. |
Baseline up to 12 weeks after last dose of study drug |
|
| Secondary |
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain. |
A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
|
| Secondary |
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee. |
A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
|
| Secondary |
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function. |
A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
|
| Secondary |
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain. |
A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
|
| Secondary |
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition. |
A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
|
| Secondary |
Number of Participants With Response to Participant Satisfaction Questionnaire |
Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied. |
A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
|
| Secondary |
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning . |
A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
|
| Secondary |
Percentage of Participants Who Discontinued the Study |
|
A4091009: Baseline up to 12 weeks after last dose of study drug |
|
| Secondary |
Median Time in Study A4091009 |
Median time of participation in the study for all the participants was evaluated. |
A4091009: Baseline up to 12 weeks after last dose of study drug |
|
