Duloxetine Versus Placebo for Osteoarthritis Knee Pain

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00408421
First received: December 6, 2006
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Osteoarthritis Knee Pain
Drug: Duloxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary [ Time Frame: Over 13 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Global Impression of Improvement at 13 Week Endpoint [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster 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 Osteoarthritis Index (WOMAC) - Stiffness Subscale [ Time Frame: Baseline and 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 Osteoarthritis Index (WOMAC) - Total Score [ 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 Worst Pain Score [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Weekly Change From Baseline in the 24-Hour Worst Pain Score [ Time Frame: Over 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - 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 - 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 - 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 - 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 Score - 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 Score - Mood [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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 Score - 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 Score - 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 Score - Sleep [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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 Average Interference [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings [ Time Frame: Over 13 Weeks ] [ Designated as safety issue: No ]
  • Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase [ Time Frame: Over 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]
  • Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
  • Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic [ 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 ]

Enrollment: 231
Study Start Date: November 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
duloxetine 30 mg, daily (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 6 weeks then duloxetine 60 mg or 120 mg QD, PO for 6 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta
Placebo Comparator: B
placebo daily (QD), by mouth (PO) for 13 weeks
Drug: placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

  • 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.
  • Acute liver injury (such as hepatitis) or severe cirrhosis.
  • Previous exposure to duloxetine.
  • Body Mass Index (BMI) over 40.
  • Major depressive disorder.
  • Daily use of narcotics.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408421

Locations
United States, Arizona
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.
Chandler, Arizona, United States, 85225
United States, California
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Beverly Hills, California, United States, 90211
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Northridge, California, United States, 91325
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Walnut Creek, California, United States, 94598
United States, Florida
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Deland, Florida, United States, 32720
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Fort Myers, Florida, United States, 33916
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S. Miami, Florida, United States, 33143
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Stuart, Florida, United States, 34996
United States, Illinois
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Chicago, Illinois, United States, 60611
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Morton Grove, Illinois, United States, 60053
United States, Massachusetts
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Billerica, Massachusetts, United States, 01821
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Waltham, Massachusetts, United States, 02453
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Westborough, Massachusetts, United States, 01581
United States, Nevada
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Reno, Nevada, United States, 89502
United States, New Jersey
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Edison, New Jersey, United States, 08817
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Stratford, New Jersey, United States, 08084
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Toms River, New Jersey, United States, 08755
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74135
United States, Texas
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Lake Jackson, Texas, United States, 77566
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Waco, Texas, United States, 76708
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Wichita Falls, Texas, United States, 76309
Puerto Rico
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Hato Rey, Puerto Rico, 00917
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San Juan, Puerto Rico, 00935
Romania
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Brasov, Romania, 500365
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Bucharest, Romania, 70266
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Cluj-Napoca, Romania, 400132
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Iasi, Romania, 700656
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

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00408421     History of Changes
Other Study ID Numbers: 10546, F1J-MC-HMEP
Study First Received: December 6, 2006
Results First Received: October 2, 2008
Last Updated: July 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 30, 2014