Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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.
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.