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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nang Kuang Pharmaceutical Co., Ltd.
• Collaborator: Taichung Veterans General Hospital
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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.