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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1) Lidoderm | Experimental | (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidoderm | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6) | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain quality using the Neuropathic Pain Scale (NPS) | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) | |
| Investigator and Patient Global Impression of Change | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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|
| Extent of numbness at the site of pain using the Numbness Questionnaire | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| Patient Global Assessment of Pain Relief | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| QoL: Pain interference (BPI Question 9) | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| QoL: Patient Global Assessment of Patch Satisfaction | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| Phoenix |
| Arizona |
| United States |
| Plantation | Florida | United States |
| Marietta | Georgia | United States |
| Burr Ridge | Illinois | United States |
| Overland Park | Kansas | United States |
| Hackensack | New Jersey | United States |
| Altoona | Pennsylvania | United States |
| Cudahy | Wisconsin | United States |
| Greenfield | Wisconsin | United States |
| West Bend | Wisconsin | United States |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D003929 | Diabetic Neuropathies |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001416 | Back Pain |
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| ID | Term |
|---|---|
| C511998 | Lidoderm |
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