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Duloxetine Versus Placebo for Osteoarthritis Knee Pain

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00408421
  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 III

MedlinePlus related topics:   Osteoarthritis   

Drug Information available for:   Duloxetine    Duloxetine hydrochloride   

U.S. FDA Resources

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Weekly mean of 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 [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Osteoarthritis Index (WOMAC) physical function, pain, and stiffness subscale [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Weekly mean of the 24-hour worst pain score [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Inventory - Severity and Interference [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Response to treatment - ≥ 30% reduction of weekly mean in 24-hour average pain severity ratings [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study Short Form-36 [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • EuroQoL Questionnaire - 5 Dimension [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory - II [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale anxiety subscale [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
  • Discontinuation rates [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
  • Treatment-emergent adverse events [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory assessments [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
  • Reduction in weekly mean of 24-hour average pain [ Time Frame: 7-13 weeks ] [ Designated as safety issue: No ]
  • Response to treatment - ≥ 30% reduction of weekly mean in 24-hour average pain severity ratings [ Time Frame: 7-13 weeks ] [ Designated as safety issue: No ]
  • Adverse Events, reported as reasons for discontinuations. [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment:   229
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
A: Experimental
duloxetine 30 mg, QD, 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
B: Placebo Comparator
placebo QD, 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.
  • BMI over 40.
  • Major depressive disorder.
  • Daily use of narcotics.
  Contacts and Locations

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
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
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
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.    
      Morton Grove, Illinois, United States, 60053
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
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.    
      Westborough, Massachusetts, United States, 01581
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.    
      Billerica, Massachusetts, United States, 01821
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.    
      Toms River, New Jersey, United States, 08755
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
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.    
      Wichita Falls, Texas, United States, 76309
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
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.    
      Iasi, Romania, 700656
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

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


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

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   10546, F1J-MC-HMEP
First Received:   December 6, 2006
Last Updated:   September 26, 2008
ClinicalTrials.gov Identifier:   NCT00408421
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Osteoarthritis, Knee
Dopamine
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Pain
Rheumatic Diseases
Serotonin
Duloxetine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 22, 2008




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