Drug Use Investigation Of Gabapentin

Overview[ - collapse ][ - ]

Purpose 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.
ConditionEpilepsies, Partial
InterventionDrug: Gabapentin
PhasePhase 4
SponsorPfizer
Responsible PartyPfizer
ClinicalTrials.gov IdentifierNCT00567268
First ReceivedNovember 16, 2007
Last UpdatedApril 24, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateNovember 16, 2007
Last Updated DateApril 24, 2014
Start DateAugust 2007
Estimated Primary Completion DateMay 2014
Current Primary Outcome Measures
  • The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [Time Frame: 12 weeks] [Designated as safety issue: No]
  • The incidence of adverse drug reactions. [Time Frame: 12 weeks] [Designated as safety issue: No]
  • Factors considered to affect the safety and/or efficacy of this drug. [Time Frame: 12 weeks] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleDrug Use Investigation Of Gabapentin
Official TitleDrug Use Investigation Of Gabapentin
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 TypeObservational
Study PhasePhase 4
Study DesignObservational Model: Case-Only, Time Perspective: Prospective
ConditionEpilepsies, Partial
InterventionDrug: 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 Arm (s)Gabapentin
Patients taking Gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment StatusEnrolling by invitation
Estimated Enrollment3000
Estimated Completion DateMay 2014
Estimated Primary Completion DateMay 2014
Eligibility Criteria
Inclusion Criteria:

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

Exclusion Criteria:

Patients not taking Gabapentin
GenderBoth
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00567268
Other Study ID NumbersA9451163
Has Data Monitoring CommitteeNo
Information Provided ByPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators Study Director: Pfizer CT.gov Call Center Pfizer
Verification DateApril 2014