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

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

This study has been terminated.

Sponsored by:	Wyeth
Information provided by:	Wyeth
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

MedlinePlus related topics:

Diabetes Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

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

Keywords provided by Wyeth:

Neuropathic Pain

Diabetic Neuropathy

Study placed in the following topic categories:

Metabolic Diseases

Neuromuscular Diseases

Diabetic Neuropathies

Peripheral Nervous System Diseases

Diabetes Mellitus

Endocrine System Diseases

Pain

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2008