Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
NCT01441401
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- 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.
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Descriptive Information | ||||
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Brief Title | 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) | |||
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:
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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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | The study whom an investigator involving A9451175 prescribes the Gabapentin | |||
Condition | Epilepsies, Partial | |||
Intervention | Drug: gabapentin
According to Japanese Package Insert: For infants and children aged 3 to 12 years, a daily dosage of 10 mg/kg of gabapentin should be administered orally in 3 divided doses on the first day of treatment, and an effective dosage of 20 mg/kg should be administered to them in 3 divided doses on day 2. From day 3 on, infants aged 3 to 4 years should be maintained on the dosage of 40 mg/kg, and children aged 5 to 12 years on the dosage of 25 to 35 mg/kg administered orally in 3 divided doses, respectively (the maximum daily dosage: 1800 mg). Though the maintenance dosage may be adjusted depending on the patient's condition, the maximum daily dosage should be 50 mg/kg. At any time point, dosage should not exceed that the dosage for adults and children aged 13 years.As for children aged 13 years or over is as same as administration for adult. | |||
Study Groups/Cohorts | Gabapentin
Peadiatric subjects taking Gabapen Tablets and syrup. Intervention: Drug: gabapentin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 82 | |||
Original Estimated Enrollment | 300 | |||
Actual Study Completion Date | September 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 3 Years to 15 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01441401 | |||
Other Study ID Numbers | A9451175 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | August 2016 |