A Study for the Treatment of Painful Diabetic Neuropathy
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Diabetic Neuropathy, Painful
Drug: Duloxetine hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy|
- Reduction in average pain severity as measured by an 11-point Likert scale.
- 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.
|Study Start Date:||October 2002|
|Study Completion Date:||March 2005|
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
|United States, Florida|
|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|
|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|