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

Phase 2TerminatedNCT00597649

XTL Biopharmaceuticals250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Chronic Peripheral Neuropathy Pain in Diabetics

Interventions

BicifadineDRUG

SR dosage form of 400 mg bid or tid for one year

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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. Contact site for additional information. 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. Contact site for additional information.

Locations (1)

Four Rivers Clinical Research

Paducah, Kentucky, United States

Outcomes

Primary Outcomes

Pain and safety

Time frame: one year

Secondary Outcomes

Clinical Global Impression of Improvement; McGill Pain Questionnaire; Amount of Rescue Medication Used for Pain; Quality of Life Survey (SF-36); Patient Global Impression of Change

Time frame: One year

Data from ClinicalTrials.gov

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