A Study for the Treatment of Painful Diabetic Neuropathy

May 16, 2007 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

660

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pembroke Pines, Florida, United States
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

April 15, 2003

First Submitted That Met QC Criteria

April 15, 2003

First Posted (Estimate)

April 16, 2003

Study Record Updates

Last Update Posted (Estimate)

May 17, 2007

Last Update Submitted That Met QC Criteria

May 16, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4097
  • F1J-MC-HMAV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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