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Trial record 1 of 1 for:    NCT00567268
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Drug Use Investigation Of Gabapentin

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ClinicalTrials.gov Identifier: NCT00567268
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : May 12, 2015
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 November 16, 2007
First Posted Date December 4, 2007
Results First Submitted Date April 23, 2015
Results First Posted Date May 12, 2015
Last Update Posted Date February 3, 2021
Study Start Date August 2007
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2015)
  • 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 Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 23, 2015)
  • 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 Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2015)
  • Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories [ Time Frame: 12 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 age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events.
  • Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline [ Time Frame: 12 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 the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events.
  • Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) [ Time Frame: 12 weeks ]
    Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy.
  • Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories [ Time Frame: 12 weeks ]
    Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy.
  • Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure [ Time Frame: 12 weeks ]
    Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial 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: 12 weeks ]
    Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) 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: 12 weeks ]
    Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories 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 Baseline Creatinine Clearance [ Time Frame: 12 weeks ]
    Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy.
  • Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy [ Time Frame: 12 weeks ]
    Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Use Investigation Of Gabapentin
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 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 patients whom an investigator involving A9451163 prescribes the Gabapentin
Condition Epilepsies, Partial
Intervention Drug: Gabapentin

GABAPEN Tablets 200mg, GABAPEN Tablets 300mg, GABAPEN Tablets 400mg. GABAPEN is Brand name in Japan.

Dosage, frequency: According to Japanese LPD, "Normally, oral gabapentin 600 mg, 3 div., should be given on the first day of administration and an effective dose of 1200mg, 3 div, should be given on day 2. From day 3 on, adults should be maintained on oral gabapentin 1200 mg to 1800 mg, 3 div. Subsequently, the maintenance dose should be suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg)".

Duration: According to the protocol of A9451163, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 12 weeks after the first administration.

Study Groups/Cohorts Gabapentin
Patients taking Gabapentin
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: June 10, 2014)
1273
Original Estimated Enrollment
 (submitted: December 3, 2007)
3000
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients need to be taking Gabapentin in order to be enrolled in the surveillance

Exclusion Criteria:

Patients not taking Gabapentin

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
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 NCT00567268
Other Study ID Numbers A9451163
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 September 2015