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Trial record 1 of 1 for:    NCT01441401
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Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01441401
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : October 6, 2016
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date September 23, 2011
First Posted Date September 27, 2011
Results First Submitted Date August 15, 2016
Results First Posted Date October 6, 2016
Last Update Posted Date February 3, 2021
Study Start Date December 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2016)
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: MAX 104 weeks ]
    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 ]
    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.
Original Primary Outcome Measures
 (submitted: September 23, 2011)
  • The frequency of treatment related adverse events. [ Time Frame: MAX 104 weeks ]
  • The frequency of efficacy assessment. [ Time Frame: MAX 104 weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: August 15, 2016)
  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: MAX 104 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures
 (submitted: September 23, 2011)
  • Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: MAX 104 weeks ]
  • Risk factors likely to affect the frequency of treatment related adverse event. [ Time Frame: MAX 104 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: August 15, 2016)
  • Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions) [ Time Frame: MAX 104 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Official Title Special 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 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study whom an investigator involving A9451175 prescribes the Gabapentin
Condition Epilepsies, Partial
Intervention 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.
Study Groups/Cohorts Gabapentin
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 Status Completed
Actual Enrollment
 (submitted: August 3, 2015)
82
Original Estimated Enrollment
 (submitted: September 23, 2011)
300
Actual Study Completion Date September 2014
Actual Primary Completion Date August 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
Ages 3 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01441401
Other Study ID Numbers A9451175
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2016