Study Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
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ClinicalTrials.gov Identifier: NCT00073034 |
Recruitment Status
:
Terminated
First Posted
: November 18, 2003
Last Update Posted
: February 21, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Diabetic Neuropathy, Painful | Drug: EAA-090 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | December 2004 |
Actual Study Completion Date : | December 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073034
Study Director: | Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00073034 History of Changes |
Other Study ID Numbers: |
0912A2-212 |
First Posted: | November 18, 2003 Key Record Dates |
Last Update Posted: | February 21, 2013 |
Last Verified: | February 2013 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Neuropathic Pain Diabetic Neuropathy |
Additional relevant MeSH terms:
Diabetic Neuropathies Diabetes Mellitus Peripheral Nervous System Diseases Neuralgia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Diabetes Complications |