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Last Updated: January 22, 2020

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CLINICAL TRIALS PROFILE FOR INFANT'S ADVIL

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505(b)(2) Clinical Trials for Infant's Advil

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01732874 DHA-1 for Lactating Mothers Active, not recruiting Children's Hospital Medical Center, Cincinnati Phase 1/Phase 2 2012-11-01 The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function. Our current intravenous (IV) fats do not contain the long chain fatty acids and different milk sources have different compositions. We would like to evaluate lactating mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of their blood and breastmilk samples after they have been supplemented with a currently used fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM) Nutritional Lipid) The DHA supplement is available over the counter. The information learned from this research study may benefit other mothers and babies in the future. The information could help make sure premature babies are receiving the right nutrients they need for appropriate growth and development.
New Dosage NCT03608696 Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure Not yet recruiting Chiesi Farmaceutici S.p.A. Phase 1/Phase 2 2018-08-29 Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.
New Dosage NCT03608696 Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure Not yet recruiting Thomas Jefferson University Phase 1/Phase 2 2018-08-29 Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Infant's Advil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000494 Management of Patent Ductus in Premature Infants Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1978-09-01 To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.
NCT00000563 Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1976-06-01 To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.
NCT00000578 NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1994-04-01 To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.
NCT00000578 NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-04-01 To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.
NCT00000580 Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1975-11-01 To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.
NCT00000590 Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185) Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1991-09-01 To determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission. Conducted in collaboration with the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases. The trial was Pediatric ACTG Protocol 185.
NCT00000590 Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1991-09-01 To determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission. Conducted in collaboration with the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases. The trial was Pediatric ACTG Protocol 185.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Infant's Advil

Condition Name

Condition Name for Infant's Advil
Intervention Trials
HIV Infections 64
Pregnancy 54
Pain 21
Malaria 20
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Condition MeSH

Condition MeSH for Infant's Advil
Intervention Trials
HIV Infections 71
Premature Birth 55
Malaria 34
Infection 26
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Clinical Trial Locations for Infant's Advil

Trials by Country

Trials by Country for Infant's Advil
Location Trials
Thailand 100
Canada 62
South Africa 30
Argentina 30
Italy 27
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Trials by US State

Trials by US State for Infant's Advil
Location Trials
California 80
Texas 68
North Carolina 60
New York 60
Pennsylvania 54
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Clinical Trial Progress for Infant's Advil

Clinical Trial Phase

Clinical Trial Phase for Infant's Advil
Clinical Trial Phase Trials
Phase 4 126
Phase 3 149
Phase 2/Phase 3 27
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Clinical Trial Status

Clinical Trial Status for Infant's Advil
Clinical Trial Phase Trials
Completed 306
Recruiting 132
Not yet recruiting 78
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Clinical Trial Sponsors for Infant's Advil

Sponsor Name

Sponsor Name for Infant's Advil
Sponsor Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 61
National Institute of Allergy and Infectious Diseases (NIAID) 56
National Heart, Lung, and Blood Institute (NHLBI) 15
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Sponsor Type

Sponsor Type for Infant's Advil
Sponsor Trials
Other 1081
NIH 188
Industry 118
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