Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
- Registration Number
- NCT01441401
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gabapentin gabapentin Peadiatric subjects taking Gabapen Tablets and syrup.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events MAX 104 weeks A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Clinical Efficacy Rate MAX 104 weeks Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure MAX 104 weeks Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (\<=8 versus \>8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.
Number of Participants With Risk Factors for Treatment-Related Adverse Events MAX 104 weeks A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by each candidate risk factor (including gender, age, and disease eligible for the survey) to assess whether these were risk factors for the treatment-related adverse events. No inferential analyses of risk factors were performed because of a small number of the events (5 events).
Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period MAX 104 weeks Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term \[less than 1 year\] or long term \[1 year or more\]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy.
Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure MAX 104 weeks Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy.
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert MAX 104 weeks A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline MAX 104 weeks Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.