A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
TerminatedPhase 2NCT00597649
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
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)
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.
Study details
- Official title
- An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- Conditions
- Chronic Peripheral Neuropathy Pain in Diabetics
- Interventions
- Sponsor
- XTL Biopharmaceuticals
- Start date
- 2007-10
- Primary completion
- 2008-12
- Sex
- All
- Age range
- from 18 Years to 90 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. * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00597649