The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
NCT ID: NCT00908453
Last Updated: 2010-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2009-05-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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15mg/kg of loading dose
fosphenytoin
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
18mg/kg of loading dose
fosphenytoin
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
22.5mg/kg of loading dose
fosphenytoin
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Interventions
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fosphenytoin
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Eligibility Criteria
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Inclusion Criteria
* Adult patients or guardian for pediatric patients to provide written informed consent
Exclusion Criteria
* patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome
* pregnant or nursing female patients
2 Years
ALL
No
Sponsors
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Nobelpharma
INDUSTRY
Responsible Party
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CNS group
Principal Investigators
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Eiji Nakagawa, M.D.
Role: STUDY_DIRECTOR
National Center of Neurology and Psychiatry
Locations
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National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
Countries
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Other Identifiers
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NPC-06-2
Identifier Type: -
Identifier Source: org_study_id
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