Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Diabetes |
| Intervention | Drug: Lidoderm |
| Phase | Phase 4 |
| Sponsor | Endo Pharmaceuticals |
| Responsible Party | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00903851 |
| First Received | May 15, 2009 |
| Last Updated | February 12, 2010 |
| Last verified | February 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2009 |
|---|---|
| Last Updated Date | February 12, 2010 |
| Start Date | April 2002 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Mean change from baseline to Week 3 in average pain intensity as measured from patient diaries using Brief Pain Inventory Question 5. [Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy |
|---|---|
| Official Title | A Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy. |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes |
| Intervention | Drug: Lidoderm Patients participated in an 8-week treatment period; patients at one site were to continue treatment for the entire 8 weeks while patients at two sites were to terminate treatment after 3 weeks. Commercially available Lidoderm® (lidocaine patch 5%) was provided to each patient with up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain. Other Names: Lidocaine Patch 5% |
| Study Arm (s) | Experimental: (1) Lidoderm (1)Commercially available Lidoderm® (lidocaine patch 5%), up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 76 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2003 |
| Eligibility Criteria | Inclusion Criteria: - At Sites 1, 2, and 3 - Had painful diabetic polyneuropathy of 3 or more months duration - At Site 1 only - Had clinical signs and symptoms of distal predominantly sensory polyneuropathy of 3 or more months duration. Diagnosis of predominantly sensory polyneuropathy were to be confirmed by either nerve conduction studies (large fiber sensory or sensorimotor axonal neuropathy) or by abnormal epidermal innervations on punch skin biopsy (distal leg/proximal thigh) (Herrmann et al., 1999; Holland et al., 1997) - Had an average daily pain rating for the baseline week of pain ratings equal to 4 or greater on the 0 to 10 numerical pain rating scale - Had at least 2 hours of moderate or severe pain intensity due to polyneuropathy daily in the immediately prior 3-month period - Were using stable analgesic drug therapy for at least 1 week (regimen and dosages) prior to screening visit, with the exception of acetaminophen and lidocaine for patients undergoing a punch skin biopsy Exclusion Criteria: - Had prior treatment with topical lidocaine, except for use with the punch skin biopsy procedure - Were currently under treatment with Class I antiarrhythmic agents (such as tocainide and mexiletine) - Had any other pain more severe than the painful diabetic or idiopathic neuropathy - Had open skin lesions in the area where the lidocaine patches were to be applied |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00903851 |
|---|---|
| Other Study ID Numbers | EN3220-005 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Endo Pharmaceuticals |
| Study Sponsor | Endo Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Study Director Endo Pharmaceuticals |
| Verification Date | February 2010 |
Locations[ + expand ][ + ]
| United States, Alabama | Birmingham, Alabama, United States |
|---|---|
| United States, Alabama | Hueytown, Alabama, United States |
| United States, Florida | Jacksonville, Florida, United States |
| United States, New York | Rochester, New York, United States |