A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 3 Fixed Doses of EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

Wyeth is now a wholly owned subsidiary of Pfizer0 sitesJanuary 2004

ConditionsDiabetes Mellitus Diabetic Neuropathy, Painful

DrugsEAA-090

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

December 2004

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility 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