Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281645
Status:
COMPLETED
Last Update Posted:
2007-03-27
First Post:
2006-01-23
Brief Title:
Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
Sponsor:
DOV Pharmaceutical Inc
Organization:
DOV Pharmaceutical Inc
Study Overview
Official Title:
A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400 mg BID for up to one year in patients with moderate to severe chronic low back pain
The secondary objectives are to compare the long-term safety of bicifadine to standard of care therapy to evaluate the safety of bicifadine following discontinuation of dosing and to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not tolerate bicifadine 400 mg BID
The secondary objectives are to compare the long-term safety of bicifadine to standard of care therapy to evaluate the safety of bicifadine following discontinuation of dosing and to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not tolerate bicifadine 400 mg BID
Detailed Description:
There are two ways by which subjects could enter this study
Subjects who completed 12 weeks of treatment in two other double blind clinical studies of bicifadine Studies 020 and 021 both in the United States could roll over into this study
Also de novo subjects that is subjects who had not previously received bicifadine could enroll in this study
Subjects who completed 12 weeks of treatment in two other double blind clinical studies of bicifadine Studies 020 and 021 both in the United States could roll over into this study
Also de novo subjects that is subjects who had not previously received bicifadine could enroll in this study
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