Special Investigation Of Gabapen For Pediatric (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 主要终点
- Number of Participants With Treatment-Related Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Gabapentin
Peadiatric subjects taking Gabapen Tablets and syrup.
干预措施: gabapentin (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events
时间窗: 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
时间窗: 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.
次要结局
- Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure(MAX 104 weeks)
- Number of Participants With Risk Factors for Treatment-Related Adverse Events(MAX 104 weeks)
- Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period(MAX 104 weeks)
- Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert(MAX 104 weeks)
- Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure(MAX 104 weeks)
- Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline(MAX 104 weeks)