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| Sponsor: | Farmacon |
|---|---|
| Information provided by: | Farmacon |
| ClinicalTrials.gov Identifier: | NCT00440804 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patent Ductus Arteriosus |
Drug: ibuprofen l-lysine iv solution (NeoProfen (R) ) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | August 2005 |
The ductus arteriosus remains patent in about 40% to 80% of very low birth weight infants. Early treatment by intravenous ibuprofen L-lysine (IV ibuprofen) has been suggested in preliminary studies to close the ductus and shorten hospital stay. This study aims to determine the effect of early treatment with IV ibuprofen given to the very low birth weight infant with a non-symptomatic patent ductus arteriosus (PDA) at less than 72 hours of life to accelerate and maintain ductal closure, thereby reducing the need for rescue therapy.
Eligibility| Ages Eligible for Study: | 28 Weeks to 34 Weeks |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | FCR-00-01/CB88 |
| Study First Received: | February 23, 2007 |
| Last Updated: | February 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00440804 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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patent ductus arterious |
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Anti-Inflammatory Agents Ibuprofen Heart Diseases Molecular Mechanisms of Pharmacological Action Cardiovascular Abnormalities Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Congenital Abnormalities Central Nervous System Agents Heart Defects, Congenital Ductus Arteriosus, Patent |