NIPH Clinical Trials Search

UMIN ID: C000000410

Registered date:26/04/2006

A phase III, efficacy and safety study of phenobarbital sodium injection in newborns with neonatal convulsion

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedneonatal convulsion
Date of first enrollment2005/11/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)phenobarbital sodium injection


Primary OutcomeRate of "excellent" cases Excellent : disapperance of convulsion Effective : improvement of degree or frequency of symptom Poor : no improvement Change in degree or frequency of convulsion 30 min. after administration
Secondary Outcome*Consistency of assessment between committee and investigator *Change in degree or frequency of convulsion 60 min. after administration

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum4weeks-old
GenderMale and Female
Include criteria
Exclude criteria1) Patients with hypersensitivity to Phenobarbital or Barbituric compounds 2) Patients with acute intermittent porphyria 3) Patients after anticonvulsant or Barbituric preparation therapy 4) Patients with any trauma except birth injury 5) Patients with therapeutic hypothermia of brain 6) Patients participated to other clinical trials 7) Patients judged as inappropriate to participate in this study by investigators

Related Information


public contact
Address Japan
Telephone 087-898-5111
Affiliation Department of Pediatrics Clinical study organizer
scientific contact
Name Susumu Itoh
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan Japan
Telephone 087-898-5111
Affiliation Kagawa University, University Hospital Department of Pediatrics