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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR CHILDREN'S IBUPROFEN


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505(b)(2) Clinical Trials for Children's Ibuprofen

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 NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Children Youth and Family Consortium Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Penn State University Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
New Indication NCT01478022 ↗ To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20 Completed Parent Project, Italy Phase 1 2011-10-01 This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose. This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular dystrophy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Children's Ibuprofen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00115336 ↗ Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease Terminated National Heart, Lung, and Blood Institute (NHLBI) Phase 4 2005-01-01 The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115336 ↗ Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease Terminated University of Texas Southwestern Medical Center Phase 4 2005-01-01 The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115336 ↗ Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease Terminated Children's Hospital Medical Center, Cincinnati Phase 4 2005-01-01 The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Children's Ibuprofen

Condition Name

Condition Name for Children's Ibuprofen
Intervention Trials
Fever 10
Pain 8
Pain, Postoperative 6
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Condition MeSH

Condition MeSH for Children's Ibuprofen
Intervention Trials
Pain, Postoperative 17
Fever 11
Fractures, Bone 8
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Clinical Trial Locations for Children's Ibuprofen

Trials by Country

Trials by Country for Children's Ibuprofen
Location Trials
United States 56
Canada 19
Israel 5
Egypt 5
Italy 3
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Trials by US State

Trials by US State for Children's Ibuprofen
Location Trials
Texas 6
Washington 5
California 4
Missouri 4
Minnesota 3
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Clinical Trial Progress for Children's Ibuprofen

Clinical Trial Phase

Clinical Trial Phase for Children's Ibuprofen
Clinical Trial Phase Trials
Phase 4 26
Phase 3 12
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Children's Ibuprofen
Clinical Trial Phase Trials
Completed 51
Recruiting 17
Unknown status 13
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Clinical Trial Sponsors for Children's Ibuprofen

Sponsor Name

Sponsor Name for Children's Ibuprofen
Sponsor Trials
Lawson Health Research Institute 4
St. Justine's Hospital 4
Children's Hospitals and Clinics of Minnesota 3
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Sponsor Type

Sponsor Type for Children's Ibuprofen
Sponsor Trials
Other 118
U.S. Fed 14
Industry 12
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