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

Phase 2

Terminated

• Conditions: Diabetes Mellitus; Diabetic Neuropathy, Painful

• Registration Number: NCT00073034
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-11-14
• Study First Submitted QC: 2003-11-17
• Study First Posted: 2003-11-18
• Study Start: 2004-01
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL