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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
Information provided by:
Eli Lilly and Company

Brief Summary:
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy, Painful Drug: Duloxetine hydrochloride Drug: placebo Phase 3

Detailed Description:
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Reduction in average pain severity as measured by an 11-point Likert scale.

Secondary Outcome Measures :
  1. Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
  2. Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
  3. Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
  4. Brief Pain Inventory to measure the severity of pain.
  5. Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
  6. Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
  7. Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

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.

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): NCT00058968

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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
Sponsors and Collaborators
Eli Lilly and Company
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00058968    
Other Study ID Numbers: 4097
First Posted: April 16, 2003    Key Record Dates
Last Update Posted: May 17, 2007
Last Verified: May 2007
Keywords provided by Eli Lilly and Company:
chronic pain
persistent pain
leg pain
peripheral neuropathy
foot pain
painful neuropathy
diabetic neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System 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
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents