Back to resultsA Study for the Treatment of Painful Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy, Painful
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duloxetine hydrochloride
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Painful focused on measuring neuropathy, pain, diabetes, chronic pain, persistent pain, leg pain, peripheral neuropathy, foot pain, painful neuropathy, diabetic neuropathy
Eligibility 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.
Sites / Locations
- 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.
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00058968
Brief Title
A Study for the Treatment of Painful Diabetic Neuropathy
Official Title
Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Detailed Description
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
Keywords
neuropathy, pain, diabetes, chronic pain, persistent pain, leg pain, peripheral neuropathy, foot pain, painful neuropathy, diabetic neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine hydrochloride
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Reduction in average pain severity as measured by an 11-point Likert scale.
Secondary Outcome Measure Information:
Title
Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
Title
Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
Title
Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
Title
Brief Pain Inventory to measure the severity of pain.
Title
Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
Title
Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
Title
Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Pembroke Pines
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17327338
Citation
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.
Results Reference
derived
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A Study for the Treatment of Painful Diabetic Neuropathy
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