Status:
COMPLETED
Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.
Eligibility Criteria
Inclusion
- Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
- May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
- Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
Exclusion
- History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study.
- Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
- Treatment with fluoxetine within 30 days of starting the study.
- Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00322621
Start Date
April 1 2006
End Date
October 1 2007
Last Update
February 7 2011
Active Locations (19)
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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.
Fortaleza, Brazil, 60120-020
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.
Porto Alegre, Brazil, 90035170
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.
Angers, France, 49033
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.
Annecy, France, 74011