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Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA

NCT00440804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2007-02-27

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

ibuprofen l-lysine iv solution (NeoProfen (R) )

Sponsors & Collaborators

  • Farmacon

    lead INDUSTRY

Principal Investigators

  • Jacob V Aranda, MD, PhD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-12-31
Completion
2005-08-31

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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 NCT00440804 on ClinicalTrials.gov