A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Postherpetic Neuralgia Diabetic Neuropathy Low Back Pain |
| Intervention | Drug: Lidoderm |
| Phase | Phase 4 |
| Sponsor | Endo Pharmaceuticals |
| Responsible Party | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00904020 |
| 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 | June 2002 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6) [Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain |
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| Official Title | A Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain |
| Brief Summary | 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. |
| 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 |
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| Intervention | Drug: Lidoderm Patients participated in a 2-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. Other Names: Lidocaine patach 5% |
| Study Arm (s) | Experimental: (1) Lidoderm (1) 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. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 107 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | November 2002 |
| Eligibility Criteria | Inclusion Criteria: - Were currently receiving an analgesic regimen that contained gabapentin - Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days) - Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory [BPI] within 24 hours prior to the screening visit - For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064) Exclusion Criteria: - Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study - Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry - Had received trigger point injections within 14 days 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) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00904020 |
|---|---|
| Other Study ID Numbers | EN3220-008 |
| 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, Arizona | Phoenix, Arizona, United States |
| United States, Florida | Plantation, Florida, United States |
| United States, Georgia | Marietta, Georgia, United States |
| United States, Illinois | Burr Ridge, Illinois, United States |
| United States, Kansas | Overland Park, Kansas, United States |
| United States, New Jersey | Hackensack, New Jersey, United States |
| United States, Pennsylvania | Altoona, Pennsylvania, United States |
| United States, Wisconsin | Cudahy, Wisconsin, United States |
| United States, Wisconsin | Greenfield, Wisconsin, United States |
| United States, Wisconsin | West Bend, Wisconsin, United States |