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Duloxetine Versus Placebo for Osteoarthritis Knee Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408421
First Posted: December 7, 2006
Last Update Posted: August 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Patient Global Impression of Improvement at 13 Week Endpoint [ Time Frame: 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score [ Time Frame: Baseline and 13 Weeks ]
  • Weekly Change From Baseline in the 24-Hour Worst Pain Score [ Time Frame: Over 13 Weeks ]
  • 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 ]
  • Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference [ Time Frame: Baseline and 13 Weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale [ Time Frame: Baseline and 13 Weeks ]
  • Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase [ Time Frame: Baseline and 13 Weeks ]
  • Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic [ Time Frame: Baseline and 13 Weeks ]
  • Change From Baseline to 13 Week Endpoint in Vital Signs - Weight [ Time Frame: Baseline and 13 Weeks ]

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

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, Senior)
Sexes Eligible for Study:   All
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
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): 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
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.
Beverly Hills, California, United States, 90211
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.
Northridge, California, United States, 91325
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.
Walnut Creek, California, United States, 94598
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.
Deland, Florida, United States, 32720
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
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.
S. Miami, Florida, United States, 33143
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.
Stuart, Florida, United States, 34996
United States, Illinois
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.
Chicago, Illinois, United States, 60611
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.
Morton Grove, Illinois, United States, 60053
United States, Massachusetts
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.
Billerica, Massachusetts, United States, 01821
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.
Waltham, Massachusetts, United States, 02453
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.
Westborough, Massachusetts, United States, 01581
United States, Nevada
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.
Reno, Nevada, United States, 89502
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
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.
Stratford, New Jersey, United States, 08084
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.
Toms River, New Jersey, United States, 08755
United States, Oklahoma
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.
Tulsa, Oklahoma, United States, 74135
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
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.
Waco, Texas, United States, 76708
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.
Wichita Falls, Texas, United States, 76309
Puerto Rico
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.
Hato Rey, Puerto Rico, 00917
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.
San Juan, Puerto Rico, 00935
Romania
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.
Brasov, Romania, 500365
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.
Bucharest, Romania, 70266
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.
Cluj-Napoca, Romania, 400132
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.
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:
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
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: October 2, 2008
Results First Posted: August 19, 2009
Last Update Posted: August 19, 2009
Last Verified: July 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