Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
Unknown statusPhase 2NCT00553592
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- Sponsor
- XTL Biopharmaceuticals
- Start date
- 2007-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00553592