Chronic Peripheral Neuropathy Pain in Diabetics Clinical Trial
Official title:
An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
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.
Status | Terminated |
Enrollment | 250 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Four Rivers Clinical Research | Paducah | Kentucky |
Lead Sponsor | Collaborator |
---|---|
XTL Biopharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain and safety | one year | Yes | |
Secondary | 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 | Yes |