CLINICAL TRIALS PROFILE FOR ASPIRIN
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505(b)(2) Clinical Trials for aspirin
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00011063 ↗ | Effect of Ginkgo Biloba on Phenytoin Elimination | Completed | National Institutes of Health Clinical Center (CC) | Phase 1 | 2001-02-01 | This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study. |
| 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. |
| OTC | NCT01669824 ↗ | Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg | Completed | Bayer | 2007-08-01 | In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication. | |
| OTC | NCT02966002 ↗ | Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients | Terminated | University of Michigan | Phase 4 | 2016-04-01 | Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for aspirin
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000151 ↗ | Early Treatment Diabetic Retinopathy Study (ETDRS) | Completed | National Eye Institute (NEI) | Phase 3 | 1979-12-01 | To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness. To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy. To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function. To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy. |
| NCT00000152 ↗ | Randomized Trial of Beta-Carotene and Macular Degeneration | Unknown status | National Eye Institute (NEI) | Phase 3 | 1982-04-01 | To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake. |
| NCT00000157 ↗ | Randomized Trial of Aspirin and Cataracts in U.S. Physicians | Terminated | National Eye Institute (NEI) | Phase 3 | 1982-04-01 | To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of developing cataract among male U.S. physicians who were aged 40 to 84 in 1982. To identify potential risk factors for cataract development, such as age, blood pressure, blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or surgery. |
| NCT00000161 ↗ | Randomized Trials of Vitamin Supplements and Eye Disease | Unknown status | National Eye Institute (NEI) | Phase 3 | 1993-08-01 | To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration (AMD) in women. To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women. To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women. To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in women. To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index, and diabetes. |
| NCT00000463 ↗ | Post Coronary Artery Bypass Graft (CABG) Study | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1987-04-01 | To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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