NCT02074267CompletedPhase 4
Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
Nang Kuang Pharmaceutical Co., Ltd.1 site in 1 country40 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Evaluation of pain intensity using the visual analog scale (VAS)
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy of Gabapentin (Carbatin & Neurontin) in patients with neuropathy pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Carbatin
Experimental
Carbatin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days
Intervention: Carbatin (Drug)
Neurontin
Active Comparator
Neurontin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days
Intervention: Neurontin (Drug)
Outcomes
Primary Outcomes
Evaluation of pain intensity using the visual analog scale (VAS)
Time Frame: up to six weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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