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

Phase 4

Completed

• Conditions: Neuropathy; Pain
• Interventions: Drug: Carbatin; Drug: Neurontin

• Registration Number: NCT02074267
• Lead Sponsor: Nang Kuang Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Status Verified: 2020-07
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbatin	Carbatin	Carbatin is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days
Neurontin	Neurontin	Neurontin is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days

Primary Outcome Measures

Name	Time	Method
Evaluation of pain intensity using the visual analog scale (VAS)	up to six weeks

Trial Locations

Locations (1)

Nang Kuang Pharmaceutical Co., LTD; 🇨🇳 Tainan, Taiwan