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

This study has been terminated.

First Received on November 14, 2003. Last Updated on May 17, 2006 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00073034

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Diabetic Neuropathy, Painful	Drug: EAA-090	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Perzinfotel

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073034

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor, MD

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00073034 History of Changes
Other Study ID Numbers:	0912A2-212
Study First Received:	November 14, 2003
Last Updated:	May 17, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Neuropathic Pain
Diabetic Neuropathy

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetic Neuropathies
Neuralgia
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Pain
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on February 12, 2012