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Completed

NCT Number: NCT00058968

A Study for the Treatment of Painful Diabetic Neuropathy

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

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Key information

Conditions

Diabetic Neuropathy, Painful Chronic Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuropathy, Painful Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

duloxetine hydrochloride

Drug

Placebo

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy

Important dates

Study start
2002
Study completion
2005
First posted
Apr 16, 2003
Registry last updated
May 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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