A Study for the Treatment of Painful Diabetic Neuropathy

Diabetic Neuropathy, Painful Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058968
• Other study ID #: 4097
• Secondary ID: F1J-MC-HMAV
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2003
• Last updated: May 16, 2007
• Start date: October 2002
• Est. completion date: March 2005

Study information

• Verified date: May 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Pain

Intervention

Drug:
• Duloxetine hydrochloride

• placebo

Locations

Country	Name	City	State
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.	Pembroke Pines	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in average pain severity as measured by an 11-point Likert scale.
Secondary	Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
Secondary	Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
Secondary	Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
Secondary	Brief Pain Inventory to measure the severity of pain.
Secondary	Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
Secondary	Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
Secondary	Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.

External Links

•   Lilly Clinical Trial Registry