Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
- Registration Number
- NCT00553592
- Lead Sponsor
- XTL Biopharmaceuticals
- Brief Summary
To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.
To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 336
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
- Others-contact site for information
Exclusion Criteria
- Symptoms of other painful conditions
- Presence of amputations other than toes
- Clinically significant psychiatric or other neurological disorder
- Use of certain medications
- Clinically important other diseases
- Pregnancy
- History of alcohol or narcotic abuse within two years
- Others-contact site for information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug Bicifadine Bicifadine Drug: 2 Bicifadine Bicifadine Control Bicifadine Placebo of Bicifadine
- Primary Outcome Measures
Name Time Method Pain and Safety 14 weeks
- Secondary Outcome Measures
Name Time Method 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 14 weeks
Trial Locations
- Locations (1)
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States