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Last Updated: April 25, 2024

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.
OTC NCT03509675 ↗ Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions. Completed University of Washington Phase 2/Phase 3 2018-04-29 Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. Current treatments for lichen planus and lichenoid mucositis are usually directed towards reducing the symptoms. This double-blinded cross-over placebo-controlled clinical trial is designed to measure the effectiveness of a topical NSAID (Ibuprofen suspension - 100mg/5ml) compared with a placebo in reducing pain associated with Oral Lichen Planus and Oral Lichenoid Lesions. Exclusion criteria include: - The occurrence of dysplasia in the histopathological specimen - Known or suspected sensitivity to NSAID medication - History of asthma - History of gastrointestinal ulceration - History of bleeding disorders - Pregnancy Outcome measures are self-reported pain scores at day 0, day 4 and day 7 of use of the placebo or active suspension, using a horizontal 100 mm, visual analog scale (VAS). If subjects were already on active treatment at the time of enrollment, they will be asked to discontinue for 7 days for a washout period before starting the research study. cord their spontaneous pain level on a 0-10 VAS. Participants will be contacted initially after the first day of the intervention to discuss any concerns or questions. Every week, reminder phone calls will be made to the subjects to fill out the forms from the investigator and to check for any side effects from the intervention. Both the patient and the investigator will be blinded for the content of each bottle.
OTC NCT05640674 ↗ Post-operative Pain Management in Children With Supracondylar Humerus Fractures Not yet recruiting Baylor College of Medicine Phase 4 2022-12-01 There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.
>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).
NCT00121563 ↗ Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect Completed National Institute of Nursing Research (NINR) Phase 2 2005-07-01 This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha modulator, on severe inflammation and relief of pain following extraction of wisdom teeth. TNFs are substances that affect the pathways of pain. This study involves an experimental group in which patients will be given thalidomide or a placebo (an inactive substance); a negative control group receiving the medication diazepam or a placebo; and a positive control group receiving diazepam or ibuprofen. Patients who are males ages 16 to 35, who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics, and who in good health may be eligible for this study. Females are not eligible, owing to the risks that thalidomide presents to unborn children. To minimize the risk of fetal malformations, male patients who participate must use a condom during sexual intercourse for 4 weeks following the study and must not donate blood for 4 weeks. The medications used in the study will be given 1 hour before surgery. Then after the wisdom teeth are removed, a small piece of tubing will be placed into both sides of the patient's mouth where the teeth were removed. Every 20 minutes, for the next 6 hours, the researchers will collect inflammatory fluid from the tubing, to measure for changes in anti-inflammatory action. If they request pain relievers, patients will receive the medication ketorolac (Toradol), used for short-term treatment of moderately severe acute pain. Side effects of thalidomide include fatigue, dizziness, and rash. The use of ibuprofen and ketorolac may include the risk of gastrointestinal ulcers and bleeding. Diazepam can cause involuntary muscle movements and drowsiness, as well as dizziness lasting for up to 24 hours after it has been used as sedation. Patients will be instructed not to try to walk alone or to try to drive a vehicle during that period. Other risks related to participation in this study include those usually experienced with removal of wisdom teeth-that is, pain and swelling, bruising from insertion of the sedative into a vein (if needed), possible infection at the extraction site, prolonged bleeding, and numbness. Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. Results from the study may help people in the future by improving the management of pain following surgery.
NCT00167713 ↗ Treatment of Fever Due to Malaria With Ibuprofen Completed Albert Schweitzer Hospital Phase 4 2003-04-01 Drugs to treat fever are widely used in children with fever. But there is a controversy about the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria. The effect of ibuprofen on fever compared to only mechanical measures is investigated in children with malaria.
NCT00240812 ↗ A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting Completed Johnson & Johnson Consumer and Personal Products Worldwide Phase 2 1969-12-31 The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.
>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
Tonsillectomy 4
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Condition MeSH

Condition MeSH for Children's Ibuprofen
Intervention Trials
Pain, Postoperative 18
Fever 11
Fractures, Bone 9
Acute Pain 5
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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 57
Canada 20
Egypt 6
Israel 5
France 3
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Trials by US State

Trials by US State for Children's Ibuprofen
Location Trials
Texas 7
Washington 5
Missouri 4
California 4
New York 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 27
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 52
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
Madigan Army Medical Center 3
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Sponsor Type

Sponsor Type for Children's Ibuprofen
Sponsor Trials
Other 120
U.S. Fed 14
Industry 12
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