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

Viatris

Status: Completed

Conditions: Epilepsies, Partial

Treatments: Drug: gabapentin

Study type: Observational

Funder types: Industry

Identifiers

NCT01441401

A9451175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

82 participants in 1 patient group

Gabapentin

Description:

Peadiatric subjects taking Gabapen Tablets and syrup.

Treatment:

Drug: gabapentin