Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-09-30

Brief Summary

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This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study:

* The frequency of treatment related adverse events.
* The frequency of efficacy assessment.
* Treatment related unlisted adverse events in Japanese Package Insert.
* Risk factors likely to affect the frequency of treatment related adverse event.

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Detailed Description

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All the patients whom an investigator prescribes the first gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions

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Epilepsies, Partial

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Gabapentin

Peadiatric subjects taking Gabapen Tablets and syrup.

gabapentin

Intervention Type DRUG

According to Japanese Package Insert: For infants and children aged 3 to 12 years, a daily dosage of 10 mg/kg of gabapentin should be administered orally in 3 divided doses on the first day of treatment, and an effective dosage of 20 mg/kg should be administered to them in 3 divided doses on day 2. From day 3 on, infants aged 3 to 4 years should be maintained on the dosage of 40 mg/kg, and children aged 5 to 12 years on the dosage of 25 to 35 mg/kg administered orally in 3 divided doses, respectively (the maximum daily dosage: 1800 mg). Though the maintenance dosage may be adjusted depending on the patient's condition, the maximum daily dosage should be 50 mg/kg. At any time point, dosage should not exceed that the dosage for adults and children aged 13 years.As for children aged 13 years or over is as same as administration for adult.

Interventions

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gabapentin

According to Japanese Package Insert: For infants and children aged 3 to 12 years, a daily dosage of 10 mg/kg of gabapentin should be administered orally in 3 divided doses on the first day of treatment, and an effective dosage of 20 mg/kg should be administered to them in 3 divided doses on day 2. From day 3 on, infants aged 3 to 4 years should be maintained on the dosage of 40 mg/kg, and children aged 5 to 12 years on the dosage of 25 to 35 mg/kg administered orally in 3 divided doses, respectively (the maximum daily dosage: 1800 mg). Though the maintenance dosage may be adjusted depending on the patient's condition, the maximum daily dosage should be 50 mg/kg. At any time point, dosage should not exceed that the dosage for adults and children aged 13 years.As for children aged 13 years or over is as same as administration for adult.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All the pediatric subjects (aged 3-15 years) whom an investigator prescribes the first gabapentin (tablets, syrup, and switch to syrup from tablet) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Exclusion Criteria

* Patients who have been enrolled in the drug use investigation of Gabapen tablets in adults (protocol No. A9451163).
* Patients who receive Gabapen tablets or syrup before, except for switched from tablets to syrup.

Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No