A Study for the Treatment of Painful Diabetic Neuropathy - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00058968

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 III

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

Publications indexed to this study:

Ziegler D, Pritchett YL, Wang F, Desaiah D, Robinson MJ, Hall JA, Chappell AS. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007 Mar;30(3):664-9.

Study ID Numbers:	4097, F1J-MC-HMAV
Study First Received:	April 15, 2003
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00058968
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

neuropathy
pain
diabetes
chronic pain
persistent pain

leg pain
peripheral neuropathy
foot pain
painful neuropathy
diabetic neuropathy

Study placed in the following topic categories:

Diabetic Neuropathies
Diabetes Mellitus
Endocrine System Diseases
Pain
Duloxetine
Serotonin
Signs and Symptoms

Dopamine
Neuromuscular Diseases
Peripheral Nervous System Diseases
Neurologic Manifestations
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Nervous System Diseases
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 January 16, 2009