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. |
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Condition | Epilepsies, Partial |
Intervention | Drug: Gabapentin |
Phase | Phase 4 |
Sponsor | Pfizer |
Responsible Party | Pfizer |
ClinicalTrials.gov Identifier | NCT00567268 |
First Received | November 16, 2007 |
Last Updated | April 24, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | November 16, 2007 |
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Last Updated Date | April 24, 2014 |
Start Date | August 2007 |
Estimated Primary Completion Date | May 2014 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Drug Use Investigation Of Gabapentin |
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Official Title | Drug 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 Type | Observational |
Study Phase | Phase 4 |
Study Design | Observational Model: Case-Only, Time Perspective: Prospective |
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 Arm (s) | Gabapentin Patients taking Gabapentin |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Enrolling by invitation |
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Estimated Enrollment | 3000 |
Estimated Completion Date | May 2014 |
Estimated Primary Completion Date | May 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 |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00567268 |
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Other Study ID Numbers | A9451163 |
Has Data Monitoring Committee | No |
Information Provided By | Pfizer |
Study Sponsor | Pfizer |
Collaborators | Not Provided |
Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
Verification Date | April 2014 |