Trials / Unknown
UnknownNCT00553592
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 336 (estimated)
- Sponsor
- XTL Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bicifadine | 600mg/day |
| DRUG | Bicifadine | placebo tablet |
| DRUG | Bicifadine | 1200 mg |
Timeline
- Start date
- 2007-09-01
- Completion
- 2008-12-01
- First posted
- 2007-11-05
- Last updated
- 2007-11-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00553592. Inclusion in this directory is not an endorsement.