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

Last updated on October 14, 2019

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Study Location
Contact
1-800-718-1021
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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Descriptive Information
Brief TitleSafety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Official TitleSpecial 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:

  • 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 DescriptionAll 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe study whom an investigator involving A9451175 prescribes the Gabapentin
ConditionEpilepsies, Partial
InterventionDrug: 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/CohortsGabapentin
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 StatusCompleted
Actual Enrollment
 (submitted: August 3, 2015)
82
Original Estimated Enrollment
 (submitted: September 23, 2011)
300
Actual Study Completion DateSeptember 2014
Actual Primary Completion DateAugust 2014   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages3 Years to 15 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01441401
Other Study ID NumbersA9451175
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2016

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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