A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Stopped early · Phase 2

Conditions studied: Chronic Peripheral Neuropathy Pain in Diabetics

In brief

This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.

Key facts

Study ID

NCT00597649

Run by

XTL Biopharmaceuticals

People needed

250

Starts

2007-10-01

Expected to finish

2008-12-01

Last updated by the study team

2009-06-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subject participated in and completed the XTL 07-001 clinical trial.
• Contact site for additional information.

You may not qualify if…

• Symptoms of other painful conditions
• Presence of amputations other than toes
• Clinically significant psychiatric or other neuropsychological disorder
• Use of certain medications
• Clinically important other diseases
• Pregnancy
• History of alcohol or narcotic abuse within two years.
• Contact site for additional information.

Where it is running

• Four Rivers Clinical Research — Paducah, Kentucky, United States

Full record on ClinicalTrials.gov

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