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Investigational compound versus Placebo in the Treatment of Painful Diabetic Neuropathy



Investigational compound versus Placebo in the Treatment of Painful Diabetic Neuropathy

For Condition: Diabetic Neuropathy, Painful
Status: No longer recruiting
Sponsor(s): Eli Lilly and Company ,
Synopsis: The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Details: The protocol will assess the efficiacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Male or female outpatients at least 18 years of age. - Patients with pain due diabetic neuropathy in both legs. - Females must not be pregnant or plan to become pregnant during the study. - Stable Glycemic control. - Average mean pain severity score of at least 4.0 as assessed by completion of a dialy diary. Exclusion Criteria: - You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company. - You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis. - You have participated in a study for an investigational drug within the last 30 days. - You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders. - You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.
Total Enrollment: 660

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Additional Information:
Study ID Numbers:
  4097; 
Study Start Date: October 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058968

Other Diabetic Neuropathy, Painful Studies:
1. Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

2. Investigational compound versus Placebo in the Treatment of Painful Diabetic Neuropathy

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