A Study for the Treatment of Painful Diabetic Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00058968|
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : May 17, 2007
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy, Painful||Drug: Duloxetine hydrochloride Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||March 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058968
|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|