CLINICAL TRIALS PROFILE FOR LIDODERM

505(b)(2) Clinical Trials for Lidoderm

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02749123 ↗	Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis	Unknown status	J.A.R. Laboratories	N/A	2016-04-01	A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.

All Clinical Trials for Lidoderm

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00266214 ↗	Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome	Terminated	Endo Pharmaceuticals	Phase 3	2005-11-01	The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine patch 5% compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome.
NCT00414453 ↗	Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis	Terminated	Endo Pharmaceuticals	Phase 4	2007-01-01	This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.
NCT00414453 ↗	Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis	Terminated	University of Rochester	Phase 4	2007-01-01	This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.
NCT00589979 ↗	Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee	Completed	Endo Pharmaceuticals	Phase 2	2007-03-01	Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.
NCT00659633 ↗	The Effect of Intravenous Lidocaine on Allodynia	Completed	American Society of Regional Anesthesia	N/A	2008-12-01	The purpose of this study is to study if lidocaine, given intravenously, reduces pain.
NCT00659633 ↗	The Effect of Intravenous Lidocaine on Allodynia	Completed	University of Alabama at Birmingham	N/A	2008-12-01	The purpose of this study is to study if lidocaine, given intravenously, reduces pain.
NCT00903851 ↗	Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy	Completed	Endo Pharmaceuticals	Phase 4	2002-04-01	Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain distal symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower extremities, or patients with idiopathic distal predominantly sensory neuropathy participated in a Phase IV clinical trial to assess the efficacy of lidocaine patches in treating painful diabetic neuropathy or idiopathic distal sensory neuropathy.

Clinical Trial Conditions for Lidoderm

Condition Name

Condition Name for Lidoderm
Intervention	Trials
Healthy	5
Postherpetic Neuralgia	3
Low Back Pain	2
Carpal Tunnel Syndrome	2

Condition MeSH

Condition MeSH for Lidoderm
Intervention	Trials
Back Pain	5
Low Back Pain	4
Neuralgia	4
Osteoarthritis, Knee	3

Clinical Trial Locations for Lidoderm

Trials by Country

Trials by Country for Lidoderm
Location	Trials
United States	81

Trials by US State

Trials by US State for Lidoderm
Location	Trials
Florida	8
Pennsylvania	7
Arizona	7
Alabama	7
New Jersey	4

Clinical Trial Progress for Lidoderm

Clinical Trial Phase

Clinical Trial Phase for Lidoderm
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Lidoderm
Clinical Trial Phase	Trials
Completed	18
Terminated	3
Unknown status	1

Clinical Trial Sponsors for Lidoderm

Sponsor Name

Sponsor Name for Lidoderm
Sponsor	Trials
Endo Pharmaceuticals	12
Scilex Pharmaceuticals, Inc.	3
CRI Lifetree	1

Sponsor Type

Sponsor Type for Lidoderm
Sponsor	Trials
Industry	18
Other	12