drugset / Trial / NCT00597649
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2008-12
- Completion
- 2008-12
Outcome
Outcome not reported
Stopped: “The 001 trial did not show benefit versus placebo”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bicifadine | Small molecule | 800 mg | — |
| Subject | Bicifadine | Small molecule | 1200 mg | — |