search
Back to results

Study 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
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Neuropathic Pain, Diabetic Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 14, 2003
    Last Updated
    February 20, 2013
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
    search

    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

    We'll reach out to this number within 24 hrs