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

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

Study Overview

• Status: Completed
• Conditions: Pain; Neuropathy
• Intervention / Treatment: Drug: Carbatin; Drug: Neurontin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 712
    • Nang Kuang Pharmaceutical Co., LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbatin; Carbatin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days	Drug: 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.
Active Comparator: Neurontin; Neurontin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of pain intensity using the visual analog scale (VAS)	up to six weeks

Collaborators and Investigators

• Sponsor: Nang Kuang Pharmaceutical Co., Ltd.
• Collaborators: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimated): February 28, 2014

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: S08174