N/A
N=82
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Epilepsies, Partial
Bottom Line
View on ClinicalTrials.gov: NCT01441401 ↗Enrolled (actual)
82
Serious AEs
4.9%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- gabapentin (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
5 | — |
| PRIMARY Clinical Efficacy Rate |
56.2; 57.7; 64.3; 42.4 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert |
— | — |
| SECONDARY Number of Participants With Risk Factors for Treatment-Related Adverse Events |
— | — |
| SECONDARY Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure |
6; 15; 6; 1 | 0.045 sig |
| SECONDARY Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure |
15; 11; 2 | 0.018 sig |
| SECONDARY Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline |
1; 13; 7; 4; 3 | 0.034 sig |
| SECONDARY Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period |
2; 26 | <0.001 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01441401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.