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CLINICAL TRIALS PROFILE FOR CHILDREN'S IBUPROFEN
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505(b)(2) Clinical Trials for Children's Ibuprofen
| 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. |
| OTC | NCT03509675 | Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions. | Not yet recruiting | University of Washington | Phase 2 | 2018-04-01 | 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 NSAID on reducing pain associated with Oral Lichen Planus and Oral Lichenoid Lesions. Potential subjects will be screened through the Oral Medicine clinic registry at the University of Washington. The topical suspension of topical NSAID 100 mg per 5 ml concentration ibuprofen with the same ingredients of over the counter children's ibuprofen will be compound will be compounded by a drug service. Another placebo suspension will also be compounded with the same taste but without the active ingredient. After obtaining written consent from the patients regarding their participation in the research, subjects will receive a research packet with relevant data forms, the consent form two bottles; each bottle with an individual code number. One will have the active ingredient and the other will be the placebo. The coding list will be with one of the committee members. Subjects will be asked to record their baseline of spontaneous pain on a horizontal 10 cm, visual analog scale (VAS) before commencing using use of the provided rinses. If subjects were already on an 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. All subjects will be instructed to use the first suspension 4 times a day for 7 days. After every application of the rinse, they will be asked to check a box to record the use of the rinse. Instructions will include to rinse with 5ml of the suspension for 1 minute without swallowing, then expectorate. Patients will be instructed to not to eat or drink for the following 20 minutes after the application of the drug. At the end of day 4 and day 7, subjects will be asked to record their spontaneous pain level on a 0-10 VAS. After the first week, the subject will discontinue any treatment for 7 days (wash-out) before starting the second suspension. All participants will be instructed to use the second suspension 4 times a day for 7 days. After every application of the rinse, they will be asked to check a box to record the use of the rinse. Instructions will include to rinse with 5ml of the suspension for 1 minute without swallowing, then expectorate. Patients will be instructed to not to eat or drink for the following 20 minutes after the application of the drug. Before using the second rinse and at the end of day 4 and day 7 of the third week, subjects will be asked to record 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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. |
| 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. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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