Trials / Terminated
TerminatedNCT00597649
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- XTL Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bicifadine | SR dosage form of 400 mg bid or tid for one year |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-01-18
- Last updated
- 2009-06-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00597649. Inclusion in this directory is not an endorsement.