Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

• Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Number of Participants Who Responded to Treatment at 13 Week Endpoint [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
• Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Adverse Events Reported as Reason for Discontinuation [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
• Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
• Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride [ Time Frame: Baseline and 13 Week Endpoint ] [ Designated as safety issue: Yes ]
• Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
• Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
• Change From Baseline to 13 Week Endpoint in Vital Signs - Weight [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
• Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
• Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
• Adverse Events Reported as Reason for Discontinuation in Nonresponders [ Time Frame: over 13 Weeks ] [ Designated as safety issue: Yes ]

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

• Drug: Duloxetine
  duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
  Other Names:

  • LY248686
  • Cymbalta
• Drug: Placebo
  placebo every day (QD), by mouth (PO) for 13 weeks

• Experimental: A
  Intervention: Drug: Duloxetine
• Placebo Comparator: B
  Intervention: Drug: Placebo

Inclusion Criteria:

• Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

• Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
• Previous exposure to duloxetine.