Diabetic Peripheral Neuropathy
Conditions
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.
Interventions
DRUGBicifadine
600mg/day
Sponsors
XTL Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain and Safety | 14 weeks |
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 | 14 weeks |
Countries
United States
Contacts
Primary ContactIvy Raso
Backup ContactKevin Barnes, MT
Outcome results
None listed