Suspended

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

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What is being tested

Data Collection

Who is being recruted

Diabetes Mellitus+12

+ Diabetic Neuropathies

+ Endocrine System Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
NCT00073034
Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetic NeuropathiesEndocrine System DiseasesMetabolic DiseasesNervous System DiseasesNeuralgiaNeurologic ManifestationsNeuromuscular DiseasesNutritional and Metabolic DiseasesPainPeripheral Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersDiabetes Complications

Criteria

3 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers