Status:
COMPLETED
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Epilepsies, Partial
Eligibility:
All Genders
3-15 years
Brief 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 trea...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01441401
Start Date
December 1 2011
End Date
September 1 2014
Last Update
February 3 2021
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