NCT00785577

A Study for Treatment of Pain in Patients With Diabetic Neuropathy.

A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects With Painful Diabetic Neuropathy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
DRUG	Placebo	LY545694 placebo BID po for 5 weeks Pregabalin placebo capsules TID po for 6 weeks
DRUG	Pregabalin	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
DRUG	LY545694 21 mg	LY545694 21 mg BID po for 1 week Pregabalin placebo TID po for 6 weeks
DRUG	LY545694 49 mg	LY545694 escalated to 49 mg BID po for 1 week during Week 2. Pregabalin placebo TID po for 6 weeks.
DRUG	LY545694 105 mg	LY545694 105 mg BID po for 5 weeks Pregabalin placebo TID po for 6 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2008-11-05
• Last updated: 2012-05-31
• Results posted: 2012-05-31

Locations

13 sites across 3 countries: United States, Mexico, Puerto Rico