Study Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

• Status: Terminated
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic neuropathy. It is a selective antagonist that binds competitively to the glutamate site of the N-methyl-D-aspartate (NMDA) receptor.

This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with placebo in subjects with neuropathic pain associated with diabetic neuropathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Criteria

Inclusion Criteria:

• Women of childbearing potential must have a negative serum pregnancy test result at screening

• Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet

• Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy

Exclusion Criteria:

• Pregnancy, lactation, or plans to become pregnant during the study

• Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control

• History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator