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Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

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NCT01441401

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-15 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01441401
Pfizer
Completed
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

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Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Special Investigation Of Gabapen For Pediatric (Regulatory Post Marketing Commitment Plan)

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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The study whom an investigator involving A9451175 prescribes the Gabapentin
Epilepsies, Partial
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.
Gabapentin
Peadiatric subjects taking Gabapen Tablets and syrup.
Intervention: Drug: gabapentin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
September 2014
August 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
3 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01441401
A9451175
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

FOR MORE INFORMATION

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1-800-718-1021

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