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The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin

Information source: Nobelpharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: fosphenytoin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Nobelpharma

Official(s) and/or principal investigator(s):
Eiji Nakagawa, M.D., Study Director, Affiliation: National Center of Neurology and Psychiatry

Summary

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.

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of adverse events

Secondary outcome: frequency and nature of seizures

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

National Center of Neurology and Psychiatry, Kodaira, Tokyo 187-8551, Japan
Additional Information

Starting date: May 2009
Last updated: May 21, 2010

Page last updated: August 23, 2015

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