Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Diabetic Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT00553592
- Run by
- XTL Biopharmaceuticals
- People needed
- 336
- Starts
- 2007-09-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2007-11-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Four Rivers Clinical Research — Paducah, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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