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OpenTrials
Completed

NCT Number: NCT02074267

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nang Kuang Pharmaceutical Co., LTD

Tainan, 712, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbatin

Drug

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.

neurontin

Drug

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.

Primary outcomes

  1. Evaluation of pain intensity using the visual analog scale (VAS)

    Time frame: up to six weeks

Sponsors and collaborators

Lead sponsor

Nang Kuang Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Taichung Veterans General Hospital

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2014
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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