NCT01441401

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

Special Investigation Of Gabapen For Pediatric (Regulatory Post Marketing Commitment Plan)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2011-09-27
• Last updated: 2021-02-03
• Results posted: 2016-10-06