Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of Gabapentin (Carbatin & Neurontin) in patients with neuropathy pain.

Conditions
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Neuropathy, Pain

Intervention / Treatment
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* Drug: Carbatin
* Drug: Neurontin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) completed a screening / baseline period before randomization. Additional disease-specific inclusion criteria are listed in Table 1. Subjects must be 20 years of age or older. Exclusion Criteria: Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives. Subjects who have a clinically significant or unstable medical or psychiatric condition. Subjects who are known of hypersensitivity to Gabapentin. Serum creatinine > 1.5 times the upper limit of normal Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period. Subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain). Subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit. Subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbatin<br>Carbatin is initiated at 100 mg at night and slowly titrated to 300 800 mg three times/day over 4 to 25 days | Drug: Carbatin<br>* Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300 800 mg three times/day over 4 to 25 days. The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.<br>|
| Active Comparator: Neurontin<br>Neurontin is initiated at 100 mg at night and slowly titrated to 300 800 mg three times/day over 4 to 25 days | Drug: Neurontin<br>* Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300 800 mg three times/day over 4 to 25 days. The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain intensity using the visual analog scale (VAS) |  | up to six weeks |