Expired Study
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Paducah, Kentucky


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00597649


Primary Contact:

Study Director
Mark Roffman, PhD
XTL Biopharmaceuticals


Backup Contact:

N/A


Location Contact:

Paducah, Kentucky
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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