Conditions: Diabetic Neuropathy, Painful
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 273
Healthy volunteers: no

Brief summary:
The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.

Detailed description:

Arms:
arm 1: LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules thrice daily (TID) po for 6 weeks arm 2: Pregabalin thrice daily (TID) oral for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6

LY545694 placebo BID po for 5 weeks arm 3: LY545694 21 milligrams (mg) BID po for 1 week

Pregabalin placebo TID po for 6 weeks arm 4: LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.

Pregabalin placebo TID po for 6 weeks arm 5: LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.

Pregabalin placebo TID po for 6 weeks

Interventions: intervention 1: Placebo intervention 2: Pregabalin intervention 3: LY545694 21 mg intervention 4: LY545694 49 mg intervention 5: LY545694 105 mg
Intervention descriptions: intervention 1: LY545694 placebo BID po for 5 weeks

Pregabalin placebo capsules TID po for 6 weeks intervention 2: Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6

LY545694 placebo BID po for 5 weeks intervention 3: LY545694 21 mg BID po for 1 week

Pregabalin placebo TID po for 6 weeks intervention 4: LY545694 escalated to 49 mg BID po for 1 week during Week 2.

Pregabalin placebo TID po for 6 weeks. intervention 5: LY545694 105 mg BID po for 5 weeks

Pregabalin placebo TID po for 6 weeks

Protocol document: