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

• ClinicalTrials.gov Identifier: NCT02074267
• Recruitment Status: Completed
• First Posted: February 28, 2014
• Last Update Posted: November 9, 2023
• Sponsor: Nang Kuang Pharmaceutical Co., Ltd.
• Collaborator: Taichung Veterans General Hospital
• Information provided by (Responsible Party): Nang Kuang Pharmaceutical Co., Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neuropathy; Pain	Drug: Carbatin; Drug: Neurontin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: March 2009
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Evaluation of pain intensity using the visual analog scale (VAS) [ Time Frame: up to six weeks ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Taiwan

Nang Kuang Pharmaceutical Co., LTD

Tainan, Taiwan, 712

Sponsors and Collaborators

Nang Kuang Pharmaceutical Co., Ltd.

Taichung Veterans General Hospital

More Information

• Responsible Party: Nang Kuang Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02074267
• Other Study ID Numbers: S08174
• First Posted: February 28, 2014
• Last Update Posted: November 9, 2023
• Last Verified: July 2020

Additional relevant MeSH terms:

Gabapentin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimanic Agents