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| Sponsored by: |
Eli Lilly and Company |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00058968 |
Purpose
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
| Condition | Intervention | Phase |
|
Diabetic Neuropathy, Painful |
Drug: Duloxetine hydrochloride Drug: placebo |
Phase III |
| MedlinePlus related topics: | Diabetic Nerve Problems |
| Drug Information available for: | Duloxetine Duloxetine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy |
| Estimated Enrollment: | 660 |
| 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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |||||
| Eli Lilly and Company |
| 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 |
More Information
Lilly Clinical Trial Registry 
  |
| Study ID Numbers: | 4097, F1J-MC-HMAV |
| First Received: | April 15, 2003 |
| Last Updated: | May 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00058968 |
| Health Authority: | United States: Food and Drug Administration |
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