A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Phase 2
Terminated
- Conditions
- Chronic Peripheral Neuropathy Pain in Diabetics
- Interventions
- Registration Number
- NCT00597649
- Lead Sponsor
- XTL Biopharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 250
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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Bicifadine Bicifadine 800 mg/day for a year 2 Bicifadine Bicifadine 1200 mg/day for a year
- Primary Outcome Measures
Name Time Method Pain and safety one year
- 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 One year
Trial Locations
- Locations (1)
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States