Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295724
Status:
COMPLETED
Last Update Posted:
2007-01-30
First Post:
2006-02-23
Brief Title:
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Sponsor:
DOV Pharmaceutical Inc
Organization:
DOV Pharmaceutical Inc
Study Overview
Official Title:
A Multi-Center Double-Blind Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients with moderate to severe chronic low back pain
The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine
The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None