CLINICAL TRIALS PROFILE FOR BICIFADINE

Clinical Trials for Bicifadine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00281645 ↗	Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain	Completed	DOV Pharmaceutical, Inc.	Phase 3	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.
NCT00295711 ↗	Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain	Completed	DOV Pharmaceutical, Inc.	Phase 3	The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo in patients with moderate to severe chronic low back pain. The secondary objectives are to investigate the dose-response relationship of three dose levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to evaluate the effect of bicifadine on function and general quality of life, to describe the population pharmacokinetics of bicifadine in patients with chronic low back pain, and to evaluate safety following discontinuation of bicifadine treatment.
NCT00295724 ↗	Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain	Completed	DOV Pharmaceutical, Inc.	Phase 3	- 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.
NCT00553592 ↗	Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes	Unknown status	XTL Biopharmaceuticals	Phase 2	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.

Clinical Trial Conditions for Bicifadine

Condition Name

Condition Name for
Intervention	Trials
Chronic Low Back Pain	3
Chronic Peripheral Neuropathy Pain in Diabetics	1
Diabetic Peripheral Neuropathy	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Low Back Pain	3
Back Pain	3
Peripheral Nervous System Diseases	2
Neuralgia	2

Clinical Trial Locations for Bicifadine

Trials by Country

Trials by Country for
Location	Trials
United States	2

Trials by US State

Trials by US State for
Location	Trials
Kentucky	2

Clinical Trial Progress for Bicifadine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Unknown status	1

Clinical Trial Sponsors for Bicifadine

Sponsor Name

Sponsor Name for
Sponsor	Trials
DOV Pharmaceutical, Inc.	3
XTL Biopharmaceuticals	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	5