Conditions: Diabetic Neuropathies
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 216
Healthy volunteers: no

Brief summary:
To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

Detailed description:

Arms:
arm 1: All subjects receive 30 mg once daily (QD), by mouth (per os - PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Patients beginning maintenance at the 60 mg QD dose could be increased to the 120 mg QD level if they did not maintain appropriate level of response throughout the maintenance period.

Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: None

Protocol document: