A Study for the Treatment of Painful Diabetic Neuropathy
|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.|
|ClinicalTrials.gov Identifier: NCT00058968|
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : May 17, 2007
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|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy, Painful||Drug: Duloxetine hydrochloride Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||March 2005|
- Reduction in average pain severity as measured by an 11-point Likert scale.
- Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
- Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
- Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
- Brief Pain Inventory to measure the severity of pain.
- Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
- Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
- Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female outpatients at least 18 years of age.
- Patients with pain due to 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 daily diary.
- 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.
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): NCT00058968
|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.|
|Pembroke Pines, Florida, United States|
|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|
|Other Study ID Numbers:||
|First Posted:||April 16, 2003 Key Record Dates|
|Last Update Posted:||May 17, 2007|
|Last Verified:||May 2007|
Peripheral Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents