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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR MEPRO-ASPIRIN


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505(b)(2) Clinical Trials for MEPRO-ASPIRIN

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 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 >Phase >Start Date >Summary

All Clinical Trials for MEPRO-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 >Phase >Start Date >Summary

Clinical Trial Conditions for MEPRO-ASPIRIN

Condition Name

Condition Name for MEPRO-ASPIRIN
Intervention Trials
Coronary Artery Disease 179
Acute Coronary Syndrome 85
Stroke 53
Myocardial Infarction 51
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Condition MeSH

Condition MeSH for MEPRO-ASPIRIN
Intervention Trials
Coronary Artery Disease 265
Myocardial Ischemia 234
Coronary Disease 216
Infarction 127
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Clinical Trial Locations for MEPRO-ASPIRIN

Trials by Country

Trials by Country for MEPRO-ASPIRIN
Location Trials
China 440
Japan 319
United Kingdom 300
Canada 295
Italy 226
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Trials by US State

Trials by US State for MEPRO-ASPIRIN
Location Trials
New York 134
Texas 128
Florida 121
California 113
Pennsylvania 108
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Clinical Trial Progress for MEPRO-ASPIRIN

Clinical Trial Phase

Clinical Trial Phase for MEPRO-ASPIRIN
Clinical Trial Phase Trials
Phase 4 516
Phase 3 334
Phase 2/Phase 3 71
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Clinical Trial Status

Clinical Trial Status for MEPRO-ASPIRIN
Clinical Trial Phase Trials
Completed 762
Unknown status 223
Recruiting 222
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Clinical Trial Sponsors for MEPRO-ASPIRIN

Sponsor Name

Sponsor Name for MEPRO-ASPIRIN
Sponsor Trials
National Cancer Institute (NCI) 54
Bayer 50
AstraZeneca 47
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Sponsor Type

Sponsor Type for MEPRO-ASPIRIN
Sponsor Trials
Other 2169
Industry 553
NIH 160
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