Clinical Trial: Drug Use Investigation Of Gabapentin

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Drug Use Investigation Of Gabapen

Brief Summary: The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

Detailed Summary: 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.
Sponsor: Pfizer

Current Primary Outcome:

• Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: 12 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 sponsor (Pfizer Japan Inc.).
• Number of Participants With Treatment-Related Adverse Events [ Time Frame: 12 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 sponsor (Pfizer Japan Inc.).
• Clinical Efficacy Rate [ Time Frame: 12 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 for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.

Original Primary Outcome:

Current Secondary Outcome:

• Response Ratio (R Ratio) [ Time Frame: 12 weeks ]
  Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.
• Responder Rate [ Time Frame: 12 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.
• Percent Reduction From Baseline in Epileptic Seizure Frequency [ Time Frame: 12 weeks ]
  Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100.

Original Secondary Outcome:

Information By: Pfizer

Dates:
Date Received: November 16, 2007
Date Started: August 2007
Date Completion:
Last Updated: September 30, 2015
Last Verified: September 2015