Topical Lidocaine Patch in Low Back Pain
Overview[ - collapse ][ - ]
| Purpose | Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP. |
|---|---|
| Condition | Acute and Chronic Non-radicular LBP |
| Intervention | Drug: Lidoderm® |
| Phase | Phase 4 |
| Sponsor | Endo Pharmaceuticals |
| Responsible Party | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00904540 |
| First Received | May 15, 2009 |
| Last Updated | February 8, 2010 |
| Last verified | February 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2009 |
|---|---|
| Last Updated Date | February 8, 2010 |
| Start Date | March 2002 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2 [Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Topical Lidocaine Patch in Low Back Pain |
|---|---|
| Official Title | Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain |
| Brief Summary | Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP. |
| 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 | Acute and Chronic Non-radicular LBP |
| Intervention | Drug: Lidoderm® Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (<6 weeks) LBP, subacute (6 weeks to <3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (>12 months LBP) Other Names: Lidocaine patch 5% |
| Study Arm (s) | Experimental: Lidoderm® Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 131 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | October 2002 |
| Eligibility Criteria | Inclusion Criteria: - Non-radicular LBP pain for ≤12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg) - Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms - Had an average daily pain intensity score of >4 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) within 24 hours prior to the screening visit. - Had a normal neurological examination, including: - Motor strength - Sensory testing (light touch, pinprick, and vibration) - Deep tendon reflexes Patients were eligible for participation in the long-term chronic (>12 months) group of the study if they also: - Had LBP for greater than one year. Patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy Exclusion Criteria: - Had a history of greater than one back surgery or one back surgery within 3 months of study entry - Had severe spinal stenosis and radicular symptoms - Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief - Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry - Had received trigger point injections within 2 weeks prior to study entry - Had received Botox Injections within 3 months prior to study entry - Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm - Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) Patients were excluded from participation in the long-term chronic (>12 months) group if they also: - Had an undefined spinal diagnosis - Had a history of lumbar spine surgery within 6 months prior to study entry |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00904540 |
|---|---|
| Other Study ID Numbers | EN3220-006 |
| 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, Arizona | Phoenix, Arizona, United States |
|---|---|
| United States, California | Mill Valley, California, United States |
| United States, Florida | Weston, Florida, United States |
| United States, New York | Bethpage, New York, United States |
| United States, North Carolina | Charlotte, North Carolina, United States |
| United States, Pennsylvania | Allentown, Pennsylvania, United States |
| United States, Wisconsin | Madison, Wisconsin, United States |