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

Study Description
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Brief Summary:

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 Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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