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

Led by XTL Biopharmaceuticals · Updated on 2007-11-05

336

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

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

Research Team

Ivy Raso

Kevin Barnes, MT

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