Drug Use Investigation Of Gabapentin

Official Title: “Drug Use Investigation Of Gabapentin”

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.

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• : Gabapentin
  • Patients taking Gabapentin

Primary Measures

• The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions).
  • Time Frame: 12 weeks
    Safety Issue?: No
• The incidence of adverse drug reactions.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Factors considered to affect the safety and/or efficacy of this drug.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• This study is a non-interventional/observational study and does not have any secondary outcomes measures
  • Time Frame: There are no secondary outcomes for this study
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not taking Gabapentin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567268

Study ID Number: A9451163

ClinicalTrials.gov Identifier: NCT00567268

Health Authority: Japan: Institutional Review Board

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