➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Moodys
Colorcon
McKesson
Baxter

Last Updated: September 22, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR CHILDREN'S IBUPROFEN

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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 Unknown status 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).
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.
>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 7
Pain, Postoperative 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Children's Ibuprofen
Intervention Trials
Pain, Postoperative 15
Fever 8
Fractures, Bone 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Children's Ibuprofen

Trials by Country

Trials by Country for Children's Ibuprofen
Location Trials
United States 47
Canada 14
Israel 5
France 3
Italy 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Children's Ibuprofen
Location Trials
Texas 6
Missouri 4
New York 3
North Carolina 3
Washington 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Children's Ibuprofen

Clinical Trial Phase

Clinical Trial Phase for Children's Ibuprofen
Clinical Trial Phase Trials
Phase 4 24
Phase 3 10
Phase 2/Phase 3 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Children's Ibuprofen
Clinical Trial Phase Trials
Completed 26
Not yet recruiting 25
Recruiting 19
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Children's Ibuprofen

Sponsor Name

Sponsor Name for Children's Ibuprofen
Sponsor Trials
St. Justine's Hospital 4
Lawson Health Research Institute 4
Assaf-Harofeh Medical Center 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Children's Ibuprofen
Sponsor Trials
Other 104
U.S. Fed 11
Industry 11
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
Express Scripts
Colorcon
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.