A Study for the Treatment of Painful Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-03-31

Brief Summary

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

Detailed Description

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

Conditions

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Diabetic Neuropathy, Painful

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Duloxetine hydrochloride

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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United States

References

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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. doi: 10.2337/dc06-2009.

Reference Type DERIVED

PMID: 17327338 (View on PubMed)

Other Identifiers

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F1J-MC-HMAV

Identifier Type: -

Identifier Source: secondary_id

4097