A Study for the Treatment of Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00058968
First received: April 15, 2003
Last updated: May 16, 2007
Last verified: May 2007
  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
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:


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
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, see Learn About Clinical Studies.

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:
No publications provided by Eli Lilly and Company

Additional 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
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
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014