UnknownPhase 2

Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

United States336 participantsStarted 2007-09

Plain-language 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.

Who can participate

Age range18 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 * 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

What they're measuring

Pain and Safety

Timeframe: 14 weeks

Trial details

NCT IDNCT00553592

SponsorXTL Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Contact for this trial

Ivy Raso

845-267-0707 iraso@xtlbio.com

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials