CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 273 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
LY545694 21 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00785577
NCT00785577Phase 2Completed

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

Eli Lilly and Company·interventional·Posted Nov 5, 2008·Updated May 31, 2012

In Brief

A Phase 2 clinical trial evaluating Placebo, Pregabalin, and 3 other interventions for Diabetic Neuropathy, Painful. Completed, enrolled 273 participants across 13 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.7 years ago

Interventions

Placebodrug

LY545694 placebo BID po for 5 weeks Pregabalin placebo capsules TID po for 6 weeks

Pregabalindrug

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

LY545694 21 mgdrug

LY545694 21 mg BID po for 1 week Pregabalin placebo TID po for 6 weeks

LY545694 49 mgdrug

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

LY545694 105 mgdrug

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