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CLINICAL TRIALS PROFILE FOR LIDODERM

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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	Recruiting	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.
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.
NCT00904020	A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain	Completed	Endo Pharmaceuticals	Phase 4	2002-06-01	Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.
NCT00904202	A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions	Completed	Endo Pharmaceuticals	Phase 4	2003-01-01	Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.

Clinical Trial Conditions for Lidoderm

Condition Name

Condition Name for Lidoderm
Intervention	Trials
Healthy	5
Postherpetic Neuralgia	3
Low Back Pain	2
Pain, Postoperative	2

Condition MeSH

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

Clinical Trial Locations for Lidoderm

Trials by Country

Trials by Country for Lidoderm
Location	Trials
United States	65

Trials by US State

Trials by US State for Lidoderm
Location	Trials
Florida	7
Pennsylvania	6
Arizona	6
Alabama	5
New York	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	2

Clinical Trial Status

Clinical Trial Status for Lidoderm
Clinical Trial Phase	Trials
Completed	14
Terminated	3
Recruiting	2

Clinical Trial Sponsors for Lidoderm

Sponsor Name

Sponsor Name for Lidoderm
Sponsor	Trials
Endo Pharmaceuticals	11
Scilex Pharmaceuticals, Inc.	3
Oregon Health and Science University	1

Sponsor Type

Sponsor Type for Lidoderm
Sponsor	Trials
Industry	17
Other	8