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

NCT ID: NCT02074267

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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Neuropathy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Carbatin

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

Group Type EXPERIMENTAL

Carbatin

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Neurontin

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role collaborator

Nang Kuang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nang Kuang Pharmaceutical Co., LTD

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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S08174

Identifier Type: -

Identifier Source: org_study_id

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