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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo capsules + placebo patch | Placebo Comparator | Placebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing |
|
| placebo capsules + Lidoderm patch (Lidocaine Group) | Experimental | Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing |
|
| Gabapentin capsules 1800 mg/day + placebo patch | Active Comparator | Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain |
|
| Gabapentin capsules 1800 mg/day + Lidoderm patch | Other | Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Capsules + Placebo Patch | Drug | Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily pain intensity (BPI Questions 3,4,5, and 6) | Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Quality Assessment Scale (PQAS) | ||
| Investigator and Patient Global Impression of Change | ||
| Allodynia Testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr 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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|
|
| Placebo capsules + Lidoderm® | Drug | Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). |
|
|
| Gabapentin + Placebo | Drug | Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). |
|
|
| Gabapentin + Lidoderm® | Drug | Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group). |
|
|
| Gabapentin 300 mg capsules 1800 mg/day + placebo patch | Drug | Gabapentin 300 mg capsules 1800 mg/day + placebo patch |
|
| Gabapentin 1800 mg/day + Lidoderm patch | Drug |
|
| QoL; Symptom Checklist, pain interference with QoL |
| Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8) |
| Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination |
| Hueytown |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Pembroke Pines | Florida | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Altoona | Pennsylvania | United States |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D003929 | Diabetic Neuropathies |
| D020918 | Complex Regional Pain Syndromes |
| D002349 | Carpal Tunnel Syndrome |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| 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 |
| D001342 | Autonomic Nervous System Diseases |
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C511998 | Lidoderm |
| D000077206 | Gabapentin |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
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