Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
NCT ID: NCT02074267
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2009-03-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Carbatin
Carbatin is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days
Carbatin
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.
Neurontin
Neurontin is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days
Neurontin
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.
Interventions
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Carbatin
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.
Neurontin
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Taichung Veterans General Hospital
OTHER
Nang Kuang Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Nang Kuang Pharmaceutical Co., LTD
Tainan City, , Taiwan
Countries
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Other Identifiers
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S08174
Identifier Type: -
Identifier Source: org_study_id
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