Back to resultsStudy Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
Primary Purpose
Diabetes Mellitus, Diabetic Neuropathy, Painful
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EAA-090
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Neuropathic Pain, Diabetic Neuropathy
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00073034
First Posted
November 14, 2003
Last Updated
February 20, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00073034
Brief Title
Study Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Neuropathy, Painful
Keywords
Neuropathic Pain, Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
EAA-090
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
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