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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00073034
• Other study ID #: 0912A2-212
• Status: Terminated
• Phase: Phase 2
• First received: November 14, 2003
• Last updated: February 20, 2013
• Start date: January 2004
• Est. completion date: December 2004

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Neuralgia

Intervention

Drug:
• EAA-090

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer