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

Wyeth

Status and phase

Terminated

Phase 2

Conditions

Diabetes Mellitus

Diabetic Neuropathy, Painful

Treatments

Drug: EAA-090

Study type

Interventional

Funder types

Industry

Identifiers

NCT00073034

0912A2-212

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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