A Long-term Study for the Treatment of Painful Diabetic Neuropathy

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Shionogi
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.