Trial record 14 of 614 for:
A Study for the Treatment of Painful Diabetic Neuropathy
This study has been completed.
Information provided by:
Eli Lilly and Company
First received: April 15, 2003
Last updated: May 16, 2007
Last verified: May 2007
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Diabetic Neuropathy, Painful
Drug: Duloxetine hydrochloride
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy
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.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058968
|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 |
Eli Lilly and Company
||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
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 15, 2003
||May 16, 2007
||United States: Food and Drug Administration
Keywords provided by Eli Lilly and Company:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 19, 2014
Peripheral Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Dopamine Uptake Inhibitors