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.

Tracking Information

• First Submitted Date: February 24, 2014
• First Posted Date: February 28, 2014
• Last Update Posted Date: November 9, 2023
• Study Start Date: March 2009
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 26, 2014): Evaluation of pain intensity using the visual analog scale (VAS) [ Time Frame: up to six weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
• Official Title: Not Provided
• Brief Summary: The purpose of this study is to assess the efficacy of Gabapentin (Carbatin & Neurontin) in patients with neuropathy pain.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Neuropathy
• Pain

Intervention

• 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.

• 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.

Study Arms

• 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
  Intervention: Drug: Carbatin
• 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
  Intervention: Drug: Neurontin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 26, 2014): 40
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT02074267
• Other Study ID Numbers: S08174
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nang Kuang Pharmaceutical Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Nang Kuang Pharmaceutical Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Taichung Veterans General Hospital
• Investigators: Not Provided
• PRS Account: Nang Kuang Pharmaceutical Co., Ltd.
• Verification Date: July 2020