Status:
TERMINATED
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Lead Sponsor:
Pfizer
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a trial to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of \[S,S\...
Eligibility Criteria
Inclusion
- Male or female of any race at least 18 years of age
- Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
- Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale
Exclusion
- Patients with significant hepatic impairment
- Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
- Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
- Amputations other than toes
- A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
- History of transient ischemic attack or stroke
- Myocardial infarction or unstable angina within the past three months
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00625833
Start Date
December 1 2007
End Date
November 1 2008
Last Update
December 13 2019
Active Locations (56)
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1
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35235
3
Pfizer Investigational Site
Mission Viejo, California, United States, 92691
4
Pfizer Investigational Site
Denver, Colorado, United States, 80209