Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01441401
First received: September 23, 2011
Last updated: August 15, 2016
Last verified: August 2016
  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
Epilepsies, Partial
Drug: gabapentin

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:
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
    A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  • Clinical Efficacy Rate [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.


Secondary Outcome Measures:
  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
    A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  • Number of Participants With Risk Factors for Treatment-Related Adverse Events [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
    A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by each candidate risk factor (including gender, age, and disease eligible for the survey) to assess whether these were risk factors for the treatment-related adverse events. No inferential analyses of risk factors were performed because of a small number of the events (5 events).

  • Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy.

  • Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 versus >8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.

  • Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.

  • Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term [less than 1 year] or long term [1 year or more]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy.


Other Outcome Measures:
  • Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions) [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
    Central nervous system depressant actions including somnolence and ataxia were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined according to MedDRA/J version 17.1 as the events classified in "psychiatric disorders" or "nervous system disorders" of the system organ classes, or those classified in "asthenia" or "gait disturbance" of the preferred terms. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.

  • Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors) [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
    Aggressive behaviors including affect lability and hostility were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined as the 101 preferred terms listed by pharmaceuticals and medical devices agency and classified according to MedDRA/J version 17.1. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.

  • Response Ratio (R Ratio) [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    R Ratio was calculated by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: R Ratio = (T - B) / (T + B). R Ratio is within the range of -1 to +1, and a negative value represents a reduction in the frequency of seizure.

  • Responder Rate [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    Responder rate, which was defined as the percentage of participants whose R ratio was - 0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of - 0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.

  • Reduction From Baseline in Epileptic Seizure Frequency [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
    Reduction from baseline in epileptic seizure frequency was defined by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: Reduction from baseline in epileptic seizure frequency (%) = [(T-B) / B] X 100. The median percentages were presented along with the corresponding minimum and maximum percentages.


Enrollment: 82
Study Start Date: December 2011
Study Completion Date: September 2014
Primary Completion Date: August 2014 (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   (Child)
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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01441401     History of Changes
Other Study ID Numbers: A9451175 
Study First Received: September 23, 2011
Results First Received: August 15, 2016
Last Updated: August 15, 2016
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
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents

ClinicalTrials.gov processed this record on December 02, 2016