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Clinical Study of Caffeine for Apnea of Prematurity

NCT01408173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-10-30

No results posted yet for this study

Summary

The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.

Conditions

  • Apnea of Prematurity

Interventions

DRUG

NPC-11 for intravenous or oral administration.

NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Principal Investigators

  • Susumu Itoh, MD, PhD · Kagawa University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01408173 on ClinicalTrials.gov