Completed PHASE3 INTERVENTIONAL NCT00440804

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

Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus

Sponsor: Farmacon

Conditions Patent Ductus Arteriosus

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

Updated 4 times since 2017 Last updated: Feb 23, 2007 Started: Dec 31, 2002 Completion: Aug 31, 2005

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00440804, this PHASE3 trial focuses on Patent Ductus Arteriosus and remains completed. Sponsored by Farmacon, it has been updated 4 times since 2002, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

4 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2017 — Jan 2021 [monthly]

Completed PHASE3

First recorded

Dec 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Farmacon

Data source: Farmacon

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.