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.
Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Patients not taking Gabapentin
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | 1273 | |||
| Original Estimated Enrollment | 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 |
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| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2015 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
