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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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

Additional Information:

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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00058968 History of Changes
Other Study ID Numbers:	4097, F1J-MC-HMAV
Study First Received:	April 15, 2003
Last Updated:	May 16, 2007
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

Additional relevant MeSH terms:

Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning

Substance-Related Disorders
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012