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

This study has been terminated.
Study NCT00073034.   Last updated on May 17, 2006.   Information provided by Wyeth

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Descriptive Information Fields
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
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.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Diabetes Mellitus
Diabetic Neuropathy, Painful
Intervention  Drug: EAA-090
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment 
Start Date 
Completion Date
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00073034
Organization ID 0912A2-212
Secondary IDs ††
Study Sponsor  Wyeth
Collaborators ††
Investigators 
Study Director:     Medical Monitor, MD     Wyeth    
Information Provided By Wyeth
Verification Date May 2006
First Received Date  November 14, 2003
Last Updated Date May 17, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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