The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
May 21, 2010 updated by: Nobelpharma
The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Kodaira, Tokyo, Japan, 187-8551
- National Center of Neurology and Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male or female, hospitalized patients 2 years of age or older
- Adult patients or guardian for pediatric patients to provide written informed consent
Exclusion Criteria:
- patient with a history of hypersensitivity to hydantoins
- patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome
- pregnant or nursing female patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 15mg/kg of loading dose
|
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
|
|
Experimental: 18mg/kg of loading dose
|
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
|
|
Experimental: 22.5mg/kg of loading dose
|
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of adverse events
Time Frame: 8 to 12 days
|
8 to 12 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
frequency and nature of seizures
Time Frame: 8 to 12 days
|
8 to 12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eiji Nakagawa, M.D., National Center of Neurology and Psychiatry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
May 21, 2009
First Submitted That Met QC Criteria
May 22, 2009
First Posted (Estimate)
May 25, 2009
Study Record Updates
Last Update Posted (Estimate)
May 24, 2010
Last Update Submitted That Met QC Criteria
May 21, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPC-06-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.