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

XTL Biopharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Chronic Peripheral Neuropathy Pain in Diabetics

Treatments: Drug: Bicifadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00597649

2007-003638-40

XTL B07-002

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

1

Experimental group

Description:

Bicifadine 800 mg/day for a year

Treatment:

Drug: Bicifadine

2

Experimental group

Description:

Bicifadine 1200 mg/day for a year

Treatment:

Drug: Bicifadine