Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes



Status:Completed
Conditions:Diabetic Neuropathy, Neurology
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:September 2007
End Date:December 2008
Contact:Ivy Raso
Email:iraso@xtlbio.com
Phone:845-267-0707

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Trial Summary
Trial Overview
Inclusion Criteria

A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with
placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating
of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.

To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens
treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral
neuropathy.


Inclusion Criteria:

- Male or female, 18 years or older

- Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus

- Chronic bilateral pain due to diabetic neuropathy

- Pain for at least six months

- Primary pain is located in the feet

- Others-contact site for information

Exclusion Criteria:

- Symptoms of other painful conditions

- Presence of amputations other than toes

- Clinically significant psychiatric or other neurological disorder

- Use of certain medications

- Clinically important other diseases

- Pregnancy

- History of alcohol or narcotic abuse within two years

- Others-contact site for information
We found this trial at
1
site
Four Rivers Clinical Research
Paducah, Kentucky 42003
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mi
from
Paducah, KY
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