Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This study is enrolling participants by invitation only.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01441401
First received: September 23, 2011
Last updated: April 29, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
U.S. FDA Resources
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: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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 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: | April 29, 2013 |
| 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 May 16, 2013