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Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

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ClinicalTrials.gov Identifier: NCT00433290
Recruitment Status : Completed
First Posted : February 9, 2007
Results First Posted : August 24, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Knee Pain Drug: Duloxetine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
Study Start Date : February 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: A 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
Placebo Comparator: B Drug: Placebo
placebo every day (QD), by mouth (PO) for 13 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in Brief Pain Inventory (BPI) 24-hour Average Rating [ Time Frame: Baseline, Week 4, Week 7, Week 13 ]

Secondary Outcome Measures :
  1. Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) [ Time Frame: 13 Weeks ]
  2. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale [ Time Frame: Baseline and 13 Weeks ]
  3. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale [ Time Frame: Baseline and 13 Weeks ]
  4. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale [ Time Frame: Baseline and 13 Weeks ]
  5. 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 ]
  6. Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline and 13 Weeks ]
  7. Number of Participants Who Responded to Treatment at 13 Week Endpoint [ Time Frame: 13 Weeks ]
  8. 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 ]
  9. Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: Baseline and 13 Weeks ]
  10. Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline and 13 Weeks ]
  11. Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [ Time Frame: Baseline and 13 Weeks ]
  12. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score [ Time Frame: Baseline and 13 Weeks ]
  13. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score [ Time Frame: Baseline and 13 Weeks ]
  14. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score [ Time Frame: Baseline and 13 Weeks ]
  15. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score [ Time Frame: Baseline and 13 Weeks ]
  16. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity [ Time Frame: Baseline and 13 Weeks ]
  17. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood [ Time Frame: Baseline and 13 Weeks ]
  18. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability [ Time Frame: Baseline and 13 Weeks ]
  19. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work [ Time Frame: Baseline and 13 Weeks ]
  20. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People [ Time Frame: Baseline and 13 Weeks ]
  21. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep [ Time Frame: Baseline and 13 Weeks ]
  22. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life [ Time Frame: Baseline and 13 Weeks ]
  23. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference [ Time Frame: Baseline and 13 Weeks ]
  24. Adverse Events Reported as Reason for Discontinuation [ Time Frame: over 13 weeks ]
  25. Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes [ Time Frame: Baseline and 13 Weeks ]
  26. Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride [ Time Frame: Baseline and 13 Week Endpoint ]
  27. Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate [ Time Frame: Baseline and 13 Weeks ]
  28. Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure [ Time Frame: Baseline and 13 Weeks ]
  29. Change From Baseline to 13 Week Endpoint in Vital Signs - Weight [ Time Frame: Baseline and 13 Weeks ]
  30. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders [ Time Frame: Baseline and 13 Weeks ]
  31. Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint [ Time Frame: 13 Weeks ]
  32. Adverse Events Reported as Reason for Discontinuation in Nonresponders [ Time Frame: over 13 Weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433290


Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Myers, Florida, United States, 33916
United States, New Jersey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edison, New Jersey, United States, 08817
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lake Jackson, Texas, United States, 77566
Greece
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Athens, Greece, 14561
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Heraklion, Greece, 71110
Russian Federation
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Moscow, Russian Federation, 119992
Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gothenburg, Sweden, 40014
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00433290     History of Changes
Other Study ID Numbers: 11198
F1J-MC-HMFG
First Posted: February 9, 2007    Key Record Dates
Results First Posted: August 24, 2009
Last Update Posted: September 2, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents