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

NCT ID: NCT00073034

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus Diabetic Neuropathy, Painful

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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EAA-090

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0912A2-212

Identifier Type: -

Identifier Source: org_study_id

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