Chronic Peripheral Neuropathy Pain in Diabetics
Conditions
Brief 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.
Interventions
DRUGBicifadine
SR dosage form of 400 mg bid or tid for one year
Sponsors
XTL Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain and safety | one year |
Secondary
| Measure | Time frame |
|---|---|
| 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 | One year |
Countries
United States
Outcome results
None listed