Status:
TERMINATED
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
Lead Sponsor:
Pfizer
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of \[S,S\]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy
Eligibility Criteria
Inclusion
- Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
- Patients at screening must have a score \>/=40 mm on the pain visual analogue scale
Exclusion
- Patients with significant hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00348894
Start Date
July 1 2006
End Date
October 1 2007
Last Update
June 1 2011
Active Locations (93)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85050
4
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85254