Clinical trial NCT01441401: Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Official title: Special Investigation Of Gabapen For Pediatric (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsies, Partial
Keywords: Gabapentin
Epilepsies
safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-27
Enrollment: 82
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study whom an investigator involving A9451175 prescribes the Gabapentin

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 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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: MAX 104 weeks
measure: Clinical Efficacy Rate
timeFrame: MAX 104 weeks
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: MAX 104 weeks
measure: Number of Participants With Risk Factors for Treatment-Related Adverse Events
timeFrame: MAX 104 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure
timeFrame: MAX 104 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure
timeFrame: MAX 104 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline
timeFrame: MAX 104 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period
timeFrame: MAX 104 weeks
Other outcomes:
measure: Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)
timeFrame: MAX 104 weeks
measure: Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)
timeFrame: MAX 104 weeks
measure: Response Ratio (R Ratio)
timeFrame: MAX 104 weeks
measure: Responder Rate
timeFrame: MAX 104 weeks
measure: Reduction From Baseline in Epileptic Seizure Frequency
timeFrame: MAX 104 weeks
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: