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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01441401
First received: September 23, 2011
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.

Condition Intervention Phase
Epilepsies, Partial
Drug: gabapentin
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The frequency of treatment related adverse events. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
  • The frequency of efficacy assessment. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
  • Risk factors likely to affect the frequency of treatment related adverse event. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gabapentin
Peadiatric subjects taking Gabapen Tablets and syrup.
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study whom an investigator involving A9451175 prescribes the Gabapentin

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441401

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01441401     History of Changes
Other Study ID Numbers: A9451175
Study First Received: September 23, 2011
Last Updated: August 22, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Pfizer:
Gabapentin
Epilepsies
safety

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on August 28, 2014