Drug Use Investigation Of Gabapentin

NCT00567268

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Patients not taking Gabapentin

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Advanced Information
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
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2015