Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores |
|
Baseline, Week 1 |
No |
Primary |
Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 2 |
No |
Primary |
Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 3 |
No |
Primary |
Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 4 |
No |
Primary |
Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 5 |
No |
Primary |
Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 6 |
No |
Primary |
Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 7 |
No |
Primary |
Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 8 |
No |
Primary |
Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 9 |
No |
Primary |
Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 10 |
No |
Primary |
Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 11 |
No |
Primary |
Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 12 |
No |
Primary |
Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores |
|
Baseline, Week 13 |
No |
Secondary |
Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint |
|
Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference |
|
Baseline, Week 13 |
No |
Secondary |
Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward |
|
Baseline to Week 13 |
No |
Secondary |
Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward |
|
Baseline to Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score |
|
Baseline, Week 13 |
No |
Secondary |
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale |
|
Baseline, Week 13 |
No |
Secondary |
Adverse Events Reported as Reason for Discontinuation |
|
Baseline to Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure |
|
Baseline, Week 13 |
Yes |
Secondary |
Change From Baseline to Week 13 Endpoint in Vital Signs - Weight |
|
Baseline, Week 13 |
Yes |