Drug Use Investigation Of Gabapentin
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsies, Partial
Intervention: Gabapentin (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Drug Use Investigation Of Gabapentin
Study design: Case-Only, Prospective
Primary outcome: The incidence of adverse drug reactions.The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). Factors considered to affect the safety and/or efficacy of this drug.
Secondary outcome: This study is a non-interventional/observational study and does not have any secondary outcomes measures
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Exclusion Criteria:
- Patients not taking Gabapentin
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2007
Ending date: December 2009
Last updated: June 9, 2008
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