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A Study for the Treatment of Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00058968
First Posted: April 16, 2003
Last Update Posted: May 17, 2007
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 purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

Condition Intervention Phase
Diabetic Neuropathy, Painful Drug: Duloxetine hydrochloride Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 660
Study Start Date: October 2002
Study Completion Date: March 2005
Detailed Description:
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
  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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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): NCT00058968


Locations
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
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):
ClinicalTrials.gov Identifier: NCT00058968     History of Changes
Other Study ID Numbers: 4097
F1J-MC-HMAV
First Submitted: April 15, 2003
First Posted: April 16, 2003
Last Update Posted: May 17, 2007
Last Verified: May 2007

Keywords provided by Eli Lilly and Company:
neuropathy
pain
diabetes
chronic pain
persistent pain
leg pain
peripheral neuropathy
foot pain
painful neuropathy
diabetic neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Pain
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents