Status:
COMPLETED
Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve Pain
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is to compare the tolerability of different methods for switching from another medication to duloxetine for the management of diabetic nerve pain. The primary objective is to compare the mo...
Eligibility Criteria
Inclusion
- You must have been diagnosed with Diabetic Peripheral Neuropathic Pain.
- You must have been taking the same dose of amitriptyline once daily at bedtime for at least four (4) weeks.
- You must have stable glycemic control.
- You must be able to visit the doctor's office once a week for ten (10) weeks.
Exclusion
- You are in the acute recovery phase following myocardial infarction.
- You have Major Depressive Disorder, an Anxiety Disorder, or some other psychiatric illnesses that the doctor will ask you about.
- You are allergic to amitriptyline or duloxetine.
- You are currently taking an anticonvulsant, cisapride (Propulsid), or if you have taken an opioid for three or more consecutive days during the 14 days prior to Visit 2.
- You have uncontrolled narrow angle glaucoma.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00266643
Start Date
December 1 2005
End Date
April 1 2007
Last Update
August 3 2007
Active Locations (20)
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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.
Phoenix, Arizona, United States, 85006
2
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.
Fort Myers, Florida, United States, 33912
3
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.
Tallahassee, Florida, United States, 32308
4
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.
Honolulu, Hawaii, United States, 96813