Status:
COMPLETED
A Long-term Study for the Treatment of Painful Diabetic Neuropathy
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Shionogi
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.
Eligibility Criteria
Inclusion
- Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
- Patients who desire to receive continued treatment with LY248686 from the preceding study.
- Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
- Patients who can provide written consent in person.
Exclusion
- Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
- Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
- Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00641719
Start Date
March 1 2008
End Date
March 1 2010
Last Update
March 31 2011
Active Locations (25)
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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.
Aichi, Japan
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.
Aomori, Japan
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.
Chiba, Japan
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.
Fukui, Japan