Drug Use Investigation Of Gabapentin - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00567268

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.

Condition	Intervention	Phase
Epilepsies, Partial	Drug: Gabapentin	Phase IV

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Gabapentin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Drug Use Investigation Of Gabapentin

Further study details as provided by Pfizer:

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 ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Gabapentin Patients taking Gabapentin	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.

Groups/Cohorts

Assigned Interventions

Gabapentin

Patients taking Gabapentin

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.

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The patients whom an investigator involving A9451163 prescribes the Gabapentin

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients not taking Gabapentin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567268

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A9451163
Study First Received:	November 16, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00567268
Health Authority:	Japan: Institutional Review Board

Keywords provided by Pfizer:

Post-Marketing surveillance

Study placed in the following topic categories:

Epilepsies, Partial
Excitatory Amino Acids
Calcium, Dietary
Gabapentin

Epilepsy
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009