Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00433290
First received: February 7, 2007
Last updated: August 26, 2009
Last verified: August 2009

February 7, 2007
August 26, 2009
February 2007
May 2008   (final data collection date for primary outcome measure)
Change in Brief Pain Inventory (BPI) 24-hour Average Rating [ Time Frame: Baseline, Week 4, Week 7, Week 13 ] [ Designated as safety issue: No ]
To assess the efficacy of duloxetine versus placebo on the reduction of pain over a 12-week period.
Complete list of historical versions of study NCT00433290 on ClinicalTrials.gov Archive Site
  • 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 comparison between duloxetine and placebo on the endpoint PGI-I; The comparison between duloxetine and placebo on the change from baseline to endpoint on the WOMAC physical function score.
Not Provided
Not Provided
 
Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Greece,   Russian Federation,   Sweden
 
NCT00433290
11198, F1J-MC-HMFG
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP