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

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XTL Biopharmaceuticals

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.

• Subject participated in and completed the XTL 07-001 clinical trial.

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Exclusion Criteria:

• 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.

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