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

This study has been completed.
Sponsor:
Information provided by:
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00908453
First received: May 21, 2009
Last updated: May 21, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: fosphenytoin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 8 to 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency and nature of seizures [ Time Frame: 8 to 12 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15mg/kg of loading dose Drug: fosphenytoin
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Experimental: 18mg/kg of loading dose Drug: fosphenytoin
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Experimental: 22.5mg/kg of loading dose Drug: fosphenytoin
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908453

Locations
Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Eiji Nakagawa, M.D. National Center of Neurology and Psychiatry
  More Information

No publications provided

Responsible Party: Nobelpharma Co., Ltd., CNS group
ClinicalTrials.gov Identifier: NCT00908453     History of Changes
Other Study ID Numbers: NPC-06-2
Study First Received: May 21, 2009
Last Updated: May 21, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nobelpharma:
NPC-06
fosphenytoin
phenytoin
pharmacokinetics
safety

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Fosphenytoin
Phenytoin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014