A Study for the Treatment of Painful Diabetic Neuropathy
Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy
2 other identifiers
interventional
660
1 country
1
Brief Summary
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 15, 2003
CompletedFirst Posted
Study publicly available on registry
April 16, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedMay 17, 2007
May 1, 2007
April 15, 2003
May 16, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in average pain severity as measured by an 11-point Likert scale.
Secondary Outcomes (7)
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.
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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
Related Publications (1)
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.
PMID: 17327338DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2003
First Posted
April 16, 2003
Study Start
October 1, 2002
Study Completion
March 1, 2005
Last Updated
May 17, 2007
Record last verified: 2007-05