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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000410

Enrollment

Registered

2006-04-26

Start date

2005-11-01

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatal convulsion

Interventions

phenobarbital sodium injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria: 1) 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

Design outcomes

Primary

Measure	Time frame
Rate 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

Measure	Time frame
Consistency of assessment between committee and investigator Change in degree or frequency of convulsion 60 min. after administration	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026