TerminatedPhase 2

A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Stopped: The 001 trial did not show benefit versus placebo

United States250 participantsStarted 2007-10

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pain and safety

Timeframe: one year

Trial details

NCT IDNCT00597649

SponsorXTL Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-12

View on ClinicalTrials.gov More Chronic Peripheral Neuropathy Pain in Diabetics trials