CLINICAL TRIALS PROFILE FOR NEOPROFEN

All Clinical Trials for NEOPROFEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00833365 ↗	Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure	Terminated	H. Lundbeck A/S	N/A	2009-01-01	The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.
NCT00833365 ↗	Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure	Terminated	University of Utah	N/A	2009-01-01	The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.
NCT00961753 ↗	Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates	Terminated	OSF Healthcare System	Phase 4	2009-08-01	The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
NCT02268955 ↗	Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic	Completed	Maricopa Integrated Health System	N/A	2014-09-09	The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous ibuprofen will provide a clinically significant drop in self-reported patient pain level as measured by the visual analog scale.
NCT02268955 ↗	Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic	Completed	Valleywise Health	N/A	2014-09-09	The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous ibuprofen will provide a clinically significant drop in self-reported patient pain level as measured by the visual analog scale.
NCT02344225 ↗	Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2015-01-01	Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.
NCT02344225 ↗	Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)	Completed	Food and Drug Administration (FDA)	Phase 2	2015-01-01	Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.

Clinical Trial Conditions for NEOPROFEN

Condition Name

Condition Name for NEOPROFEN
Intervention	Trials
Patent Ductus Arteriosus	2
Biliary Colic	1
Prematurity	1
Retinopathy of Prematurity	1

Condition MeSH

Condition MeSH for NEOPROFEN
Intervention	Trials
Ductus Arteriosus, Patent	2
Retinopathy of Prematurity	1
Colic	1

Clinical Trial Locations for NEOPROFEN

Trials by Country

Trials by Country for NEOPROFEN
Location	Trials
United States	4

Trials by US State

Trials by US State for NEOPROFEN
Location	Trials
New York	1
Arizona	1
Illinois	1
Utah	1

Clinical Trial Progress for NEOPROFEN

Clinical Trial Phase

Clinical Trial Phase for NEOPROFEN
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for NEOPROFEN
Clinical Trial Phase	Trials
Completed	2
Terminated	2

Clinical Trial Sponsors for NEOPROFEN

Sponsor Name

Sponsor Name for NEOPROFEN
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
Food and Drug Administration (FDA)	1
State University of New York - Downstate Medical Center	1

Sponsor Type

Sponsor Type for NEOPROFEN
Sponsor	Trials
Other	5
NIH	1
U.S. Fed	1