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

Nang Kuang Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Neuropathy

Pain

Treatments

Drug: Carbatin

Drug: Neurontin

Study type

Interventional

Funder types

Other

Industry

Identifiers

S08174

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.